Agency classClass IIOur severity:Severe FDA (Devices)·Z-2174-2020·Announced 2020-06-10

FDA Recalls Sterile Surgical Packs Due to Unregistered Facility

American Contract Systems is recalling 2,868 sterile surgical packs because they were manufactured in a facility not registered by the FDA.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, which corresponds to a Severe severity score per the rubric, as it involves a reasonable probability of temporary or medically reversible adverse health consequences.

Plain-English summary

American Contract Systems is recalling 2,868 sterile custom packs intended for use in surgical procedures. The recall was initiated because the surgical gowns included in these packs were manufactured in a facility that is not registered by the FDA.

The affected products are identified by ACS Tray Number FBCS38I. The recall includes 4 kits from Lot # 692191 with an expiration date of 11/04/2020, and 40 kits from Lot # 648191 with an expiration date of 12/18/2020. These products were distributed nationwide in the United States, including in the state of Pennsylvania.

The FDA has classified this as a Class II recall. Consumers and healthcare facilities should stop using the affected sterile custom packs and contact American Contract Systems for further instructions.

The recalled product

Product: Sterile Custom Packs to be used in surgical procedures.
Manufacturer: American Contract Systems
Category: Medical Device — Surgical Packs
Hazard: unregistered-facility
sterility-compromise
Affected units: 2,868

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 (4)

ACS Tray Numbers: FBCS38I
Lot # 692191
Exp. Date 11/04/2020 (4 kits) and Lot # 648191
Exp. Date 12/18/2020 (40 kits)

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 14 recalled by American Contract Systems 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 14 products in this recall →

Same manufacturer · American Contract Systems

See all →

Moderate
FDA Recalls Sterile Surgical Packs from Unregistered Facility
FDA (Devices) · 2020-06-10
High
FDA Recalls Sterile Surgical Packs from Unregistered Facility
FDA (Devices) · 2020-06-10
High
FDA Recalls Sterile Custom Surgical Packs Due to Unregistered Facility
FDA (Devices) · 2020-06-10
High
FDA Recalls Sterile Custom Surgical Packs from Unregistered Facility
FDA (Devices) · 2020-06-10
Moderate
FDA Recalls Surgical Gowns from Unregistered Facility
FDA (Devices) · 2020-06-10

Same hazard · unregistered facility