Lap Pack Convenience Kits Recalled for Sterility Assurance Concerns
American Contract Systems is recalling 500 Lap Pack - 170307 convenience kits distributed in Arizona due to sterility assurance concerns with procedure trays.
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: This is an FDA Class II medical device recall involving a potential sterility failure in procedure trays. Non-sterile medical devices used in clinical procedures present a significant infection risk, though no illnesses have been reported.
Plain-English summary
American Contract Systems, Inc. is recalling Lap Pack - 170307 convenience kits due to sterility assurance concerns with the procedure trays included in the kits.
The affected kits carry Lot 9219420 (UDI-DI 00191072233776) with an expiration date of 01/21/2026. A total of 500 kits were distributed in Arizona.
Healthcare facilities and users in possession of affected kits should contact American Contract Systems, Inc. or their healthcare provider for further guidance regarding these kits.
The recalled product
- Product
- Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Catalog Number: BHLP62H Software Version: N/A Product Description: Convenience Kit Component: No
- Manufacturer
- American Contract Systems, Inc.
- Affected units
- 500
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 (3)
- Lot Code: UDI-DI: 00191072233776
- Lot: 9219420
- Exp: 01/21/2026
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 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.
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