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U.S. Department of Health and Human Services

Class 2 Device Recall McKesson Lap Sponge

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  Class 2 Device Recall McKesson Lap Sponge see related information
Date Initiated by Firm August 11, 2021
Create Date September 14, 2021
Recall Status1 Terminated 3 on July 07, 2023
Recall Number Z-2473-2021
Recall Event ID 88561
Product Classification Gauze/sponge, internal, x-ray detectable - Product Code GDY
Product McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile McKesson Part # 16-2112121
Code Information Lot number: CJJ12-07
Recalling Firm/
Manufacturer		 Cypress Medical Products LLC
9954 Mayland Dr
Richmond VA 23233-1464
For Additional Information Contact Mike Morzuch
815-345-1406
Manufacturer 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
FDA Determined
Cause 2		 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 in Commerce 1 case (40 packs/cs)
Distribution VA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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