Neurology Surgical Packs Recalled for Sterilization Validation Failure
American Contract Systems recalls 37 units of neurology surgical packs distributed across 13 US states due to exposure to multiple sterilization cycles without proper validation.
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: This is an FDA Class II recall of medical device kits used in surgical procedures. The hazard—exposure to multiple sterilization cycles without validation—represents a risk-of-harm situation because inadequate sterilization could allow contamination during use. No illnesses or injuries have been reported, meeting the criterion for Score 3: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
American Contract Systems, Inc. is recalling 37 units of various neurology surgical packs distributed to health systems and distributors in Arizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Ohio, Nebraska, Pennsylvania, Rhode Island, South Dakota, and Texas.
The packs were exposed to multiple sterilization cycles without validation that they could safely withstand repeated sterilization. This creates a potential contamination risk, as adequate sterilization is critical to prevent microorganisms from surviving on surgical instruments and materials used in procedures.
No illnesses or injuries have been reported to date. Healthcare facilities that received these products should identify affected units using the tray numbers, sterilization lot numbers, and bag serial numbers listed in the FDA recall notice and quarantine them immediately. Do not use affected packs in surgical procedures. Contact American Contract Systems, Inc. for instructions on returning or replacing recalled units.
The recalled product
- Product
- Various neurology packs
- Manufacturer
- American Contract Systems, Inc.
- Category
- Medical Device — Surgical Packs
- Hazard
- sterilization-failure
- contamination-risk
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)
- Tray Number
- Sterilization Lot
- Lot Number
- Bag Serial Number 1) LSRLMNEINTC
- 2105181
- 870211
- 63990989 2) LSRSWRSPNC
- 2105251
- 861211
- 63990357 3) LSRLMNEUROG
- 2106161
- 845211
- 44139500 4) LSRSMHNEURE
- 2108101
- 793211
- 44139500 5) LSRNEURCRANIH
- 2108171
- 776211
- 64123199 6) LSRLMNEUROG
- 2110011
Distribution
Distributed in 13 states:
- AZ
- FL
- IA
- IL
- MA
- MN
- MO
- NE
- OH
- PA
- RI
- SD
- TX
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