Z-2473-2021Class II

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

Name: Z-2473-2021 McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile McKesson Part # 16-2112121
Creator: Cypress Medical Products LLC
Published: 2021-08-11
License: https://open.fda.gov/license/

Cypress Medical Products LLC / initiated 2021-08-11 / Terminated / root cause: software

FDA source

Cypress Medical Products LLC began a recall of McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile McKesson Part # 16-2112121 on 2021-08-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2473-2021
Classification: Class II
Status: Terminated
Initiated: 2021-08-11
Posted: 2021-09-14
Terminated: 2023-07-07
Recalling firm: Cypress Medical Products LLC
Product: McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile McKesson Part # 16-2112121
Product code: GDY Gauze/Sponge, Internal, X-Ray Detectable
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
Root cause tag: software
FDA 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 [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
Quantity in commerce: 1 case (40 packs/cs)
Distribution: VA
Product codes and lots: Lot number: CJJ12-07

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2473-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2473-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-22	2021-09-14

Product code GDY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)