Basic biopsy trays recalled after entire lot was sterilized more than once
American Contract Systems is recalling a Basic Biopsy Tray lot that was re-gassed after a sterilization nonconformance, without validation for multiple cycles.
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: Scored 3 under the risk-of-harm criterion: quality and safety cannot be confirmed for kits used in invasive procedures, and no injuries are reported.
Plain-English summary
The Basic Biopsy Tray, item number NMBP44L, is being recalled.
The identified products were re-gassed, meaning sterilized more than once, after a nonconformance occurred during the initial ethylene oxide gas injection process. These products have not been validated for exposure to multiple sterilization cycles, so product quality, safety and effectiveness cannot be confirmed.
The action covers 32,433 units in total across the firm's affected kits. This item carries UDI-DI 191072188120, and the record states the entire lot 8515411 is impacted. The product was distributed in South Dakota, Iowa, Minnesota, Washington and Illinois. The FDA has classified the action as Class II.
Facilities should identify affected stock, quarantine it and follow the firm's instructions.
The recalled product
- Product
- Basic Biopsy Tray, Item Number NMBP44L
- Manufacturer
- American Contract Systems Inc.
- Category
- Medical Device — Surgical kit
- Affected units
- 32,433
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 191072188120 Lot 8515411 Entire lot impacted
Distribution
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.
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