Arthroscopy Procedure Tray Recalled for Sterilant Residual Contamination
American Contract Systems Inc is recalling 272 units of the ARTHROSCOPY SUP JOI PACK Procedure Tray because sterilant residuals in the cast padding exceeded safe limits for permanent implant use.
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 for sterilant residual contamination in a surgical device used in permanent body contact. No illnesses or injuries reported, but regulatory exposure limits were exceeded per established safety standards.
Plain-English summary
American Contract Systems Inc has recalled 272 units of the ARTHROSCOPY SUP JOI PACK Procedure Tray (Catalog Number BPAS17C). The affected units have UDI-DI 00191072197825 and lot numbers 665231 and 950241. These trays were distributed nationwide.
The FDA issued a Class II recall because ethylene oxide and ethylene chlorohydrin residuals detected in the cast padding component exceeded the maximum allowable limits established by the ANSI/AAMI/ISO 10993-7/(R)2012 standard for permanent exposure devices. Sterilant residuals above these limits present a potential health risk during patient use.
Healthcare facilities that received these trays should discontinue use immediately. Users should contact American Contract Systems Inc for return or disposal instructions. No illnesses or injuries attributable to this issue have been reported.
The recalled product
- Product
- ARTHROSCOPY SUP JOI PACK Procedure tray Catalog Number: BPAS17C
- Manufacturer
- American Contract Systems Inc
- Hazard
- Affected units
- 272
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 (1)
- UDI-DI: 00191072197825 LOT#"s: 665231 950241
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 39 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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