Recall Z-2473-2021— Cypress Medical Products LLC
Class II · Terminated
Class II FDA medical device recall by Cypress Medical Products LLC, initiated 2021-08-11, terminated 2023-07-07. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.
- Recalling firm
- Cypress Medical Products LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-08-11
- Terminated
- 2023-07-07
- Firm location
- Richmond, VA, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.