FDA Medical Device Recalls (openFDA)
Cypress Medical Products LLC: McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile McKesson Part # 16-2112121
- Recall number
- Z-2473-2021
- Recalling firm
- Cypress Medical Products LLC
- Product
- McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile McKesson Part # 16-2112121
- Status
- Terminated
- Initiated
- 2021-08-11
- Posted
- not on file
- Terminated
- 2023-07-07
- 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 attached Medical Device Recall Response Form to Cypress.CustomerService@cypressmed.com. 4. Forward this notification along with the response form the end user
- Quantity
- 1 case (40 packs/cs)
- Distribution
- VA
- Lot, serial or model codes
- Lot number: CJJ12-07
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GDY
- Firm FEI
- 1451040
- Firm city
- Richmond
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28