FDA Enforcement
Class II
Terminated
McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile McKesson Part # 16-2112121
Recall: Z-2473-2021
·
Reported September 22, 2021
Enforcement
- Recall Number
- Z-2473-2021
- Event ID
- 88561
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Cypress Medical Products LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- September 22, 2021
- Initiation Date
- August 11, 2021
- Classification Date
- September 14, 2021
- Termination Date
- July 7, 2023
- Address
- 9954 Mayland Dr, N/A, Richmond, VA, 23233-1464, United States
Description
McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile McKesson Part # 16-2112121
Reason
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
Code Info
Lot number: CJJ12-07
Distribution
VA
Quantity
1 case (40 packs/cs)