Agency classClass IIOur severity:High FDA (Devices)·Z-0824-2024·Announced 2024-02-07

Custom Surgical Convenience Kits May Lack Proper Sterilization Validation

American Contract Systems, Inc. recalls surgical convenience kits whose added components may lack proper sterilization validation, potentially resulting in loss of functionality or retained sterilant residue.

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: FDA Class II medical device recall with no reported illnesses or injuries. The hazard is theoretical—components may have lost functionality or retained excessive sterilant residue—but meets the 'risk-of-harm' criterion for surgical medical devices without confirmed patient harm.

Plain-English summary

American Contract Systems, Inc. is recalling 112 units of two custom procedural convenience kits used in general and plastic surgery: the Breast Plastics Pack (BBPL20D) and MINOR PLASTIC (WPMP16H). These kits were distributed nationwide.

During an internal investigation, the manufacturer discovered that certain components were added to the sterilization trays without proper assessment or documentation of their suitability for sterilization. The added components were subjected to elevated temperatures and sterilization without validation that they could withstand these processes.

As a result, the added components may have lost functionality, may have lost drug efficacy if applicable, or may contain higher than specified ethylene oxide residuals from sterilization. These defects could affect the performance and safety of the surgical kits.

If you possess any of these kits, contact the manufacturer or your healthcare facility for instructions on handling the affected units.

The recalled product

Product: Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) Breast Plastics Pack, kit number BBPL20D; b) MINOR PLASTIC, kit number WPMP16H
Manufacturer: American Contract Systems, Inc.
Category: Medical Device — Surgical Procedural Kits
Hazard: loss-of-functionality
sterilization-failure
ethylene-oxide-residual
Affected units: 112

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)

a) BBPL20D
Lot Codes: 862221
exp. 5/18/2023
688221
exp. 5/31/2023
756221
exp. 9/1/2023
782221
exp. 8/6/2023
b) WPMP16H
Lot Codes: 904231
exp. 4/6/2024
966231
exp. 2/3/2024
650221
exp. 12/16/2023
708221
exp. 10/19/2023
805221
exp. 7/14/2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 18 recalled by American Contract Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 18 products in this recall →

Same manufacturer · American Contract Systems, Inc.

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