Recall Z-2473-2021 ยท GDY Gauze/Sponge, Internal, X-Ray Detectable
Cypress Medical Products LLC
McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile McKesson Part # 16-2112121
| Date | Aug 11, 2021 |
| Status | Terminated |
| 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 |
| Root cause | Software in the Use Environment |
| Action | Cypress Medical Products, LLC is the initial importer for McKesson Medical-Surgical, Inc. Cypress is assisting the distributor (MMS) via Urgent Medical Device Recall letter dated 8/11/21. Letter states reason for recall, health risk and action to take: 1. Cease use of the impacted lot number in your possession. Affected 2. Please contact Cypress Customer Service at ypress.CustomerService@cypressmed.com and return the impacted product to the address listed below: Cypress Medical Products, LLC Attn: Quality Assurance 20951 Walter Strawn Drive Elwood, IL 60421 3. Complete and return the attac |
| Quantity | 1 case (40 packs/cs) |
| Distribution | VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.