WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W
- Recall Initiated
- June 21, 2021
- Recall Number
- Z-2305-2021
- Quantity
- 40,000 units
Reason for Recall
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Distribution
US Nationwide distribution in the states of FL and MN.
Lot / Code Info
a) REF PIVD2010W, Lot 1100256 b) REF PIV2210W, Lot 1100316 c) REF PIV2475W, Lot 1200084
Root Cause
Process control
Action Taken
The firm disseminated the notices on 06/21/2021 by email. The firm is requesting destruction of the affected devices at the consignee.
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