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.
What this means for you
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.
- Hazard
- loss-of-functionality
- sterilization-failure
- ethylene-oxide-residual
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.
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