Agency classClass IIOur severity:High FDA (Devices)·Z-0964-2019·Announced 2019-03-06

FDA Recalls Surgical Convenience Kits Due to Potential Sterilization Failure

American Contract Systems, Inc. is recalling 51,152 surgical convenience kits distributed in Florida because they may not have reached complete sterilization.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (incomplete sterilization) where injury has not yet been reported, fitting the 'High' severity criteria.

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…
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.

Lot numbers (20)

Tray Number (Lot Number): a. Tray Number: LSRBASICPACD (1610281
1611301
1701041
1701301
1702111
1702201
1703171
1703232
1704101
1705052
1705061
1705092
1705252
1706141
1707101
1708041
1708291
1710132)
b. Tray Number: LSRCFHANGD (1611091
1701052

Distribution

Distributed in 1 state:

Same manufacturer · American Contract Systems, Inc.

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