QUIKCLOT IPN928790Recalls & reported problems
Teleflex Incorporated · QuikClot Hemostatic Dressing 4x4 ,CE,Multi-lang10x · Class U
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841495150286), received between Jun 27, 2025 and Jun 27, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Activation Problem” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K123387); they may or may not involve this specific model.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Activation Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 27, 2025Activation Problem; Activation Problem
IT WAS REPORTED THAT, "PATIENT'S PERMCATH INSERTION SITE WAS BLEEDING AND THE QUIKCLOT DID NOT HELP TO STOP THE BLEEDING. PATIENT IS STILL IN SURGICAL WARD; BLEEDING IS CURRENTLY UNDER CONTROL. IT LOOKS LIKE THE BLEEDING OCCURRED IN ICU OVER THE WEEKEND. THE DOCTOR GAVE SOMETHING TO STOP HELP STOP THE BLEEDING."
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22344145 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K123387. One submission often covers many models, so check the product and lot details in each record.
- Z-0925-2018 · Nov 17, 2017 · TerminatedQuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of se
- Z-2612-2017 · May 17, 2017 · TerminatedQuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fairfield Boulevard, Wallingford, CT 06492 USA For
Other Dressing, wound, drug devices
- MediHoney® 31815Acell, Inc. · Dressing, wound, drug2 recalls7 reports
- MediHoney® 31515Acell, Inc. · Dressing, wound, drug2 recalls6 reports
- MediHoney® 31805Acell, Inc. · Dressing, wound, drug2 recalls1 death5 reports
- MediHoney® 31535Acell, Inc. · Dressing, wound, drug2 recalls0 reports
- AQUACEL AG FOAM 420681Convatec, Purchasing Department · Dressing, Wound, Drug99 reports
- SteriCare Solutions 6240Nurse Assist, Inc. · Dressing, Wound, Drug1 recall14 reports
- MEDLINE MNK0005Medline Industries, Inc. · Dressing, wound, drug1 recall5 reports
- Medline DYND500MLSMedline Industries, Inc. · Dressing, wound, drug1 recall5 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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