Agency classClass IIOur severity:High FDA (Devices)·Z-2171-2020·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. The hazard involves the use of medical devices from an unregistered facility, which poses a risk of harm, but the source text does not report any specific illnesses, injuries, or fatalities, fitting the criteria for a High severity score.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling 2,868 sterile custom packs intended for use in surgical procedures. The recalling firm is American Contract Systems. 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 the following codes: ACS Tray Number AGLH66F, Lot # 674191 (244 kits), and ACS Tray Number AGAD45I, Lot# 681191, Exp. Date 11/15/2020 (35 kits). The source text does not specify the expiration date for the first lot. These products were distributed nationwide in the United States, including in the state of Pennsylvania.

Healthcare facilities and consumers should stop using these specific sterile custom packs immediately. The FDA classifies this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

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-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 (5)

ACS Tray Numbers: AGLH66F
Lot # 674191
Exp. Date [date] (244 kits) AGAD45I
Lot# 681191
Exp. Date 11/15/2020 (35 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