Arthroscopy Pack Recalled Due to Unconfirmed Sterilization Assurance
American Contract Systems is recalling 48 Arthroscopy Packs because humidity readings were out of specification, preventing confirmation of 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 involves a medical device where sterilization assurance cannot be confirmed, creating a risk of harm (infection) without reported injuries, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
American Contract Systems, Inc. is recalling 48 units of the Arthroscopy Pack, MSKA45A. The recall was initiated because an inoperable chart recorder resulted in out-of-specification humidity readings in a controlled environment area. Consequently, the manufacturer is unable to confirm that product sterilization assurance requirements were met.
The affected products have the UDI-DI 00191072200938, Lot 2405153, and an expiration date of 05/15/2025. These units were distributed nationwide in the states of Missouri, Minnesota, Massachusetts, Ohio, and Nebraska.
Consumers and healthcare facilities should stop using the recalled Arthroscopy Packs and contact American Contract Systems, Inc. for instructions on return or replacement.
The recalled product
- Product
- Arthroscopy Pack, MSKA45A; Medical convenience kit
- Manufacturer
- American Contract Systems, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 48
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)
- UDI-DI: 00191072200938
- Lot: 2405153
- Exp: 05/15/2025
Distribution
Part of a larger recall action
This product is one of 19 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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