FDA Recalls Surgical Convenience Kits Due to Potential Sterilization Failure

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Bag size #4 Custom Convenience Kits manufactured by American Contract Systems, Inc. The recall involves 51,152 units of surgical convenience kits that were distributed to facilities in Florida. The specific products are identified by various tray names and numbers, including PACK BASIC SET UP LH, PACK ANGIOGRAM CFH, and PACK BASIC VIII CFH, among others.

The recall was initiated because there is a potential that the products have not reached complete sterilization. This defect poses a risk of infection or other adverse health consequences to patients if the kits are used in surgical procedures. The FDA classifies this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare facilities and consumers who have these specific surgical kits should stop using them immediately. The source text does not provide specific instructions for disposal or return, but users should contact the manufacturer or their supplier for further guidance on how to handle the recalled items. No illnesses or injuries have been reported in the source text.

The recalled product

Product

Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits labeled as the following: a. Tray Name: PACK BASIC SET UP LH - 2035102, Tray Number: LSRBASICPACD; b. Tray Name: PACK ANGIOGRAM CFH - 2071297, Tray Number: LSRCFHANGD; c. Tray Name: PACK B

Manufacturer

American Contract Systems, Inc.

Category

Medical Device — Surgical Kits

Hazard

• infection-risk
• sterilization-failure

Affected units

51,152

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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