Steri-DrapeRecalls & reported problems across all models

We found 11 models of Steri-Drape by 3m Company in the FDA's device registry (GUDID). Together they are named in 7 adverse event reports in the FDA's MAUDE database, received between Mar 16, 2018 and Mar 2, 2023 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Human-Device Interface Problem” (1 report).

8 FDA recall records name at least one of these models by its device identifier, 8 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Steri-Drape recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Oct 6, 2022Open, Classified

   During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in reported adhesive related skin injuries for these affected lots.

   Z-0264-2023 · Root cause: Component change control · Recall details · FDA record ↗

2. Oct 6, 2022Open, Classified

   During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in reported adhesive related skin injuries for these affected lots.

   Z-0262-2023 · Root cause: Component change control · Recall details · FDA record ↗

3. Oct 6, 2022Open, Classified

   During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in reported adhesive related skin injuries for these affected lots.

   Z-0260-2023 · Root cause: Component change control · Recall details · FDA record ↗

4. Oct 6, 2022Open, Classified

   During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in reported adhesive related skin injuries for these affected lots.

   Z-0257-2023 · Root cause: Component change control · Recall details · FDA record ↗

5. Oct 6, 2022Open, Classified

   During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in reported adhesive related skin injuries for these affected lots.

   Z-0255-2023 · Root cause: Component change control · Recall details · FDA record ↗

6. Oct 6, 2022Open, Classified

   During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in reported adhesive related skin injuries for these affected lots.

   Z-0253-2023 · Root cause: Component change control · Recall details · FDA record ↗

7. Oct 6, 2022Open, Classified

   During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in reported adhesive related skin injuries for these affected lots.

   Z-0250-2023 · Root cause: Component change control · Recall details · FDA record ↗

8. Oct 6, 2022Open, Classified

   During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in reported adhesive related skin injuries for these affected lots.

   Z-0247-2023 · Root cause: Component change control · Recall details · FDA record ↗

Most reported Steri-Drape problems

Steri-Drape models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Steri-Drape™ 1010

  Drape, surgical, exempt
  1 recall3 reports
• Steri-Drape™ 1071

  Drape, surgical, exempt
  1 recall0 reports
• Steri-Drape™ 1060

  Drape, surgical, exempt
  1 recall0 reports
• Steri-Drape™ 1030

  Drape, surgical, exempt
  1 recall0 reports
• Steri-Drape™ 1020

  Drape, surgical, exempt
  1 recall0 reports
• Steri-Drape™ 1000

  Drape, surgical, exempt
  1 recall0 reports
• Steri-Drape™ 1021

  Drape, surgical, exempt
  1 recall0 reports
• Steri-Drape™ 1061

  Drape, surgical, exempt
  1 recall0 reports
• Steri-Drape™ 1015

  Drape, surgical, exempt
  2 reports
• Steri-Drape™ 2045

  Drape, surgical, exempt
  1 report
• Steri-Drape™ 1013

  Drape, surgical, exempt
  1 report

Recent Steri-Drape adverse event reports

The 7 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2023Human-Device Interface Problem; Human-Device Interface Problem

  ON 01/19/2023, THE FOLLOWING INFORMATION WAS PROVIDED TO 3M: THE CUSTOMER REPORTED THAT THE PATIENT'S SKIN ALLEGEDLY LIFTED UPON REMOVAL OF THE 3M¿ STERI-DRAPE¿ U-DRAPE, 1015, LOT 33KYPX. NO MEDICAL INTERVENTIONS WERE REPORTED. 3M MADE MULTIPLE UNSUCCESSFUL FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WITH NO RESPONSE. ON 02/16/2023, 3M RECEIVED FDA VIA MEDWATCH FORM MW1047429 THAT INDICATED MEDICAL TREATMENT WAS REQUIRED; HOWEVER, SPECIFIC INFORMATION REGARDING THE TYPE OF TREATMENT PROVIDED WAS NOT SPECIFIED.

  Patient problems: Skin Tears

  MAUDE report 16471781 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MATERIALS MANAGER REPORTED THAT A PATIENT ALLEGEDLY EXPERIENCED A 5CM X 1.5CM FULL THICKNESS ARM SKIN TEAR FROM A 3M¿ STERI-DRAPE¿ LARGE TOWEL DRAPE WITH MINIMAL BLEEDING THAT RESOLVED WITH PRESSURE. THE SURGEON SUBSEQUENTLY REAPPLIED THE SKIN WITH SKIN GLUE, AND THE WOUND IS IMPROVING. A SKIN PREPARATION WAS APPLIED POST 3M¿ STERI-DRAPE¿ LARGE TOWEL DRAPE APPLICATION. NO OTHER PRODUCTS WERE APPLIED PRIOR TO THE APPLICATION OF THE DRAPE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Tears

  MAUDE report 15251242 ↗
• InjurySep 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INTENSE ITCHINESS AND A RASH DEVELOPED UNDER THE EDGE OF A 3M STERI-DRAPE U-DRAPE THAT WAS APPLIED DURING A PARTIAL LEFT HIP REVISION SURGERY. DIPHENHYDRAMINE WAS ADMINISTERED INTRAVENOUSLY, AND THE SYMPTOMS RESOLVED. THE ITCHINESS OCCURRED ON THE CHEST BELOW THE BREAST AREA AFTER THE SURGERY ENDED AND THE RASH WAS OBSERVED WHEN THE DRAPE WAS REMOVED. CHLORHEXIDINE GLUCONATE WAS USED FOR SKIN PREPARATION PRIOR TO THE SURGERY; SKIN PREPARATION PRODUCTS APPLIED AT THE REACTION SITE IS UNKNOWN.

  Patient problems: Itching Sensation; Rash

  MAUDE report 12530413 ↗
• InjuryAug 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT A PATIENT DEVELOPED SUSPECTED CONTACT DERMATITIS, DESCRIBED AS SKIN RASH WITH REDNESS, ITCHINESS AND BLISTERS ALONG THE DRAPE EDGES AFTER APPLICATION OF A 3M¿ STERI-DRAPE¿ LARGE TOWEL DRAPE 1010 DURING SPINAL SURGERY. THE RASH IS LOCATED ON THE ANTERIOR NECK/SUPERIOR TORSO REGION, SIZE REPORTED AS GREATER THAN 25X6CM AT THE LARGEST LINEAR REGION. SKIN PREPARATION INCLUDED APPLICATION OF MASTISOL® LIQUID ADHESIVE. THE SKIN WAS REPORTED AS DRY PRIOR TO APPLICATION OF THE DRAPE. THE DRAPE WAS IN PLACE 1-2 DAYS BEFORE THE SYMPTOMS BEGAN. MEDICAL TREATMENT CONSISTED OF INTRAVENOUS, ORAL, AND TOPICAL CORTICOSTEROIDS. HEALING IS IN PROGRESS AND THE PATIENT IS REPORTED AS IN STABLE CONDITION.

  Patient problems: Erythema; Itching Sensation; Rash

  MAUDE report 10376373 ↗
• InjuryMar 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANAPHYLACTIC REACTION WAS REPORTED THAT OCCURRED SIX DAYS AFTER A CERVICAL FUSION SURGERY PROTECTED BY A 3M¿ STERI-DRAPE¿ LARGE TOWEL DRAPE 1010. A MEDICAL ALERT BAND WAS WORN THE DAY OF SURGERY DUE TO PRIOR SKIN REACTIONS WITH ADHESIVES. THE CONSUMER WENT TO THE EMERGENCY ROOM SIX DAYS AFTER SURGERY DUE TO SYMPTOMS OF FACIAL ITCHINESS WITH A BURNING SENSATION AND FACIAL AND THROAT SWELLING. AN INTRAVENOUS INFUSION OF DIPHENHYDRAMINE AND A STEROID WAS ADMINISTERED, AND THE SYMPTOMS RESOLVED. THE CONSUMER WAS DISCHARGED FROM THE EMERGENCY ROOM THE SAME DAY. SKIN REDNESS UNDER THE ADHESIVE AREA OF THE 3M¿ STERI-DRAPE¿ LARGE TOWEL DRAPE 1010 WAS ALSO OBSERVED.

  Patient problems: Anaphylactic Shock; Burning Sensation; Erythema; Itching Sensation; Swelling

  MAUDE report 9899124 ↗
• MalfunctionMar 22, 2019Melted; Material Split, Cut or Torn; Physical Resistance/Sticking

  STERILE BARRIER ISSUE WITH C-ARM DRAPES X 2 W/ SAME LOT NUMBER. THE FIRST DRAPE SEEMED TO BE MELTED & STUCK TOGETHER; 2ND DRAPE WAS SPLIT OPEN, NOT INTACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8443241 ↗
• InjuryMar 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HOSPITAL EMPLOYEE REPORTED A PATIENT EXPERIENCED A SKIN INJURY WHEN A 2045 3M¿ STERI-DRAPE¿ 2 INCISE DRAPE WAS REMOVED FOLLOWING A LAPAROTOMY PROCEDURE.

  Patient problems: Skin Tears

  MAUDE report 7346369 ↗

Other 3m Company products

• 3M Attest5 models · 1 reports · 4 recalls
• 3M Steri-Drape4 models · 0 reports · 4 recalls
• Ranger10 models · 176 reports
• 3M Ranger3 models · 73 reports · 1 recall
• Attest2 models · 0 reports · 2 recalls
• 3M Red Dot8 models · 16 reports · 1 recall
• Fast Release Varnish2 models · 2 reports · 1 recall
• Comply3 models · 1 reports · 1 recall