Agency classClass IIOur severity:High FDA (Devices)·Z-2179-2020·Announced 2020-06-10

FDA Recalls Sterile Custom Surgical Packs from Unregistered Facility

American Contract Systems is recalling 2,868 sterile custom 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 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: The recall is classified as FDA Class II, which indicates a reasonable probability of temporary or medically reversible adverse health consequences. The hazard involves the use of unregistered facility products in surgical procedures, representing a risk of harm where injury has not yet been reported.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for sterile custom packs intended for use in surgical procedures. The recalling firm, American Contract Systems, is recalling a total of 2,868 kits. The specific reason for the recall is that 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 AVLC19G, Lot # 642191, and an expiration date of 12/24/2020. This specific lot consists of 64 kits. The products were distributed nationwide in the United States, including in the state of Pennsylvania.

Healthcare facilities and consumers who have these specific sterile custom packs should stop using them immediately and contact American Contract Systems for further instructions on how to return or dispose of the product.

The recalled product

Product: Sterile Custom Packs to be used in surgical procedures.
Manufacturer: American Contract Systems
Category: Medical Device — Surgical Supplies
Hazard: unregistered-facility
contamination-risk
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 (3)

ACS Tray Numbers: AVLC19G
Lot # 642191
Exp. Date 12/24/2020 (64 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
Moderate
FDA Recalls Surgical Gowns from Unregistered Facility
FDA (Devices) · 2020-06-10
High
FDA Recalls Sterile Custom Surgical Packs from Unregistered Facility
FDA (Devices) · 2020-06-10

Same hazard · unregistered facility