McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile McKesson Part # 16-2112121
This recall has been terminated (originally issued August 11, 2021).
- Company
- Cypress Medical Products Llc
- Recall Initiated
- August 11, 2021
- Terminated
- July 7, 2023
- Recall Number
- Z-2473-2021
- Quantity
- 1 case (40 packs/cs)
- Firm Location
- Richmond, VA
- Official Source
- View on FDA website ↗
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
VA
Lot / Code Info
Lot number: CJJ12-07
Root Cause
Software in the Use Environment
Action Taken
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 attached Medical Device Recall Response Form to Cypress.CustomerService@cypressmed.com. 4. Forward this notification along with the response form the end user