Z-2473-2021 Class II Terminated
FDA device recall Z-2473-2021 was initiated by Cypress Medical Products LLC on August 11, 2021 and is designated Class II. Reason for recall: Manufacturer issued a recall due to an EO indicator color. The indicator should change from red to blue signifying sterilization. However, on one case of product, the indicators did not change The recall status is terminated (terminated July 7, 2023). Affected quantity: 1 case (40 packs/cs).
Recall Details
- Product Type
- Devices
- Report Date
- September 22, 2021
- Initiation Date
- August 11, 2021
- Termination Date
- July 7, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 case (40 packs/cs)
Product Description
McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile McKesson Part # 16-2112121
Reason for Recall
Manufacturer issued a recall due to an EO indicator color. The indicator should change from red to blue signifying sterilization. However, on one case of product, the indicators did not change
Distribution Pattern
VA
Code Information
Lot number: CJJ12-07