Curity 7831Recalls & reported problems
Cardinal Health, Inc. · Iodoform Packing Strip · Class U
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521068704), received between Aug 12, 2021 and Aug 12, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 12, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE PATIENT HAD SURGERY TO REMOVE A CYST ON HER BACK IN 2021 AT THE PA-C. AT THE APPOINTMENT TO HAVE HER STITCHES REMOVED, IT WAS DETERMINED THAT THE WOUND WAS INFECTED. THE PA PACKED THE WOUND WITH EXPIRED IODOFORM PACKING STRIPS. THE EXPIRATION DATE WAS 2016-04, REF (B)(4). THE PATIENT WAS STARTED ON CEFALEXIN BID FOR 10 DAYS. ATTEMPTS HAVE BEEN CONDUCTED TO GATHER CLARIFICATION OF THE REPORTED EVENT. TO DATE, NO CLARIFICATION HAS BEEN RECEIVED TO CONFIRM IF THE IODOFORM PACKING STRIP CONTRIBUTED TO THE INFECTION. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, THE REPORT WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 12316147 ↗
Other GAUZE/SPONGE, INTERNAL devices
- McKesson 61-59220Mckesson Medical-Surgical Inc. · Gauze/Sponge, Internal1 recall0 reports
- McKesson 61-59120Mckesson Medical-Surgical Inc. · Gauze/Sponge, Internal1 recall0 reports
- McKesson 61-59320Mckesson Medical-Surgical Inc. · Gauze/Sponge, Internal1 recall0 reports
- DeRoyal 30-054Deroyal Industries, Inc. · GAUZE/SPONGE, INTERNAL16 reports
- DeRoyal 30-057Deroyal Industries, Inc. · GAUZE/SPONGE, INTERNAL11 reports
- DeRoyal 30-060Deroyal Industries, Inc. · GAUZE/SPONGE, INTERNAL5 reports
- DeRoyal 30-068Deroyal Industries, Inc. · GAUZE/SPONGE, INTERNAL4 reports
- PILLING IPN004227Teleflex Incorporated · GAUZE/SPONGE, INTERNAL4 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.