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Terminated

McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile McKesson Part # 16-2112121

FDA Recall Z-2473-2021 · Posted None

Recalling FirmCypress Medical Products LLC
Recall StatusTerminated
Product CodeGDY
Date Initiated2021-08-11
Date Terminated2023-07-07
Product Quantity1 case (40 packs/cs)

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

Firm 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 [email protected] 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 [email protected]. 4. Forward this notification along with the response form the end user

Root Cause

Software in the Use Environment

Distribution Pattern

VA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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