Custom Ear, Nose and Throat Surgical Kits Recalled Due to Sterilization Validation Failure
American Contract Systems is recalling 804 custom ear, nose and throat surgical kits nationwide because components were sterilized without validation that they could tolerate the process, potentially affecting functionality or drug efficacy.
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 a Class II device recall involving risk-of-harm surgical products where no injuries or illnesses have been reported. The theoretical hazards—potential loss of functionality and efficacy due to sterilization process validation failure—meet the criteria for High severity.
Plain-English summary
American Contract Systems, Inc. is recalling 804 custom procedural convenience kits and trays for ear, nose and throat surgery. The recalled products include T AND A PACK AGH ASC (kit number AGTA48J), OPSC EAR PACK (kit number LLEO66), and T AND A PACK (kit number MMTA41F).
During an internal investigation, the manufacturer identified that several components were added to the trays and subjected to the company's sterilization process. The manufacturer found no documentation confirming that these added components had been assessed to determine if they were suitable for exposure to elevated temperatures or the sterilization process.
As a result, the added components may experience loss or lack of functionality, loss of drug efficacy if applicable, and may have been exposed to higher than specified ethylene oxide (EO) residuals. Healthcare facilities should immediately discontinue use of these kits and contact the manufacturer for replacement or return options.
The recalled product
- Product
- Custom procedural convenience kits and trays, ear, nose & throat, labeled as: a) T AND A PACK AGH ASC, kit number AGTA48J; b) OPSC EAR PACK, kit number LLEO66; c) T AND A PACK, kit number MMTA41F
- Manufacturer
- American Contract Systems, Inc.
- Affected units
- 804
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) AGTA48J
- UDI/DI 00191072142870
- lot numbers: 890231
- exp. 45402
- 920231
- exp. 45372
- 941231
- exp. 45350
- 976231
- exp. 45315
- 645221
- exp. 45281
- 659221
- exp. 45267
- 686221
- exp. 45240
- 755221
- exp. 45171
- 836221
- exp. 45090
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 18 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.
See all 18 products in this recall →Related recalls
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