Bilateral Tubal Ligation Pack Recalled for Unconfirmed Sterilization
American Contract Systems, Inc. is recalling the Bilateral Tubal Ligation Pack (Lot 2405102) due to inability to confirm proper sterilization following a chart recorder malfunction.
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 risk-of-harm medical device where sterilization assurance cannot be confirmed. While the hazard is theoretical (no illnesses reported), the use of a potentially non-sterile surgical instrument poses a significant infection risk to patients, meeting the rubric criterion for High severity.
Plain-English summary
American Contract Systems, Inc. is recalling the Bilateral Tubal Ligation Pack, model FHBT3T (Lot 2405102, expiration 05/10/2025), a medical convenience kit used in tubal ligation procedures.
The recall was initiated because a chart recorder in one of the manufacturer's controlled environment areas became inoperable, causing humidity readings to fall out of specification. As a result, the manufacturer cannot confirm that sterilization assurance requirements were met for the affected units.
The recall affects 18 units that were distributed nationwide to facilities in Missouri, Minnesota, Massachusetts, Ohio, and Nebraska. No injuries or illnesses have been reported. Affected healthcare facilities and practitioners should contact American Contract Systems, Inc. for instructions on returning or disposing of the recalled units.
The recalled product
- Product
- Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit
- Manufacturer
- American Contract Systems, Inc.
- Category
- Medical Device — Surgical Kit
- Affected units
- 18
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: 00191072178107
- Lot: 2405102
- Exp: 05/10/2025
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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