VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS
- Company
- Stradis Healthcare
- Recall Initiated
- May 10, 2022
- Recall Number
- Z-1688-2022
- Quantity
- 520 units
- Firm Location
- Waukegan, IL
Reason for Recall
Potential for incomplete seals.
Distribution
Pennsylvania
Lot / Code Info
Part Number AMS-8465CS, UDI/DI: 00849884005622, Lot Number: 220614962, Expiration Date: 04/30/2023
Root Cause
Other
Action Taken
Stradis notified its sole consignee initially by telephone on 05/10/2022 and followed with a letter disseminated by email on 05/11/2022. The letter explained the problem, risk to health, and requested the quarantine of the affected product pending return. The letter directed the consignee to notify their customers to whom they further distributed the product to return the product to Stradis.
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