The Recall Desk
HighFDA (Devices)·Z-2311-2024·Announced 2024-07-17

Hand Pack Procedure Kit recalled for excess ethylene oxide residuals

American Contract Systems Inc is recalling the HAND PACK-Procedure Kit (catalog WEHD16C) due to ethylene oxide and ethylene chlorohydrin residuals exceeding safety limits.

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: FDA Class II recall with no reported illnesses or injuries. The hazard is a theoretical risk of harm from sterilization residues exceeding limits. Per the rubric, when no illnesses or injuries are reported and the hazard is theoretical, the score is at most 3 (High).

Plain-English summary

American Contract Systems Inc is recalling the HAND PACK-Procedure Kit, Catalog Number WEHD16C, distributed nationwide in the United States.

The cast padding component of the kit contains residuals of ethylene oxide (EO) and ethylene chlorohydrin (ECH), sterilization byproducts, that exceed the allowable limits for permanent-exposure medical devices as specified in ANSI/AAMI/ISO 10993-7 (R)2012. This standard establishes safe exposure thresholds for materials that remain in contact with the body.

Affected units include Lot 894241 (UDI-DI: 00191072217035). A total of 45 units were distributed. Patients and healthcare facilities in possession of this product should contact the manufacturer or their supplier for instructions regarding return or replacement.

The recalled product

Product
HAND PACK-Procedure Kit Catalog Number: WEHD16C
Manufacturer
American Contract Systems Inc
Category
Medical Device — Surgical Procedure Kit
Hazard
  • ethylene-oxide-residual
  • sterilization-byproduct
  • chemical-exposure

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: 00191072217035 LOT#"s: 894241

Distribution

Distributed nationwide across the United States.

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