Agency classClass IIOur severity:High FDA (Devices)·Z-2176-2020·Announced 2020-06-10

FDA Recalls Sterile Custom Surgical Packs Due to Unregistered Facility

American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered with 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, and the source text does not report any illnesses or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported are rated as High (3).

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 removing 2,868 total kits from the market. These products were distributed nationwide in the United States, including in the state of Pennsylvania.

The reason for the recall is that the surgical gowns contained in these packs were manufactured in a facility that is not registered by the FDA. This regulatory non-compliance poses a potential risk to patient safety during surgical procedures.

Healthcare facilities and consumers who have these specific kits should stop using them immediately. The affected products are identified by the following ACS Tray Numbers, Lot Numbers, and Expiration Dates: AGSBOO6K (Lot # 660191, Exp. 12/06/2020), AGDB14J (Lot # 737191, Exp. 09/20/2020), AHLA17J (Lot # 653191, Exp. 12/13/2020), SVNE16K (Lot # 691191, Exp. 11/05/2020), and WPLA17I (Lot # 685191, Exp. 11/11/2020).

The recalled product

Product: Sterile Custom Packs to be used in surgical procedures.
Manufacturer: American Contract Systems
Category: Medical Device — Surgical Supplies
Hazard: regulatory-non-compliance
unregistered-facility
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 (11)

ACS Tray Numbers: AGSBOO6K
Lot # 660191
Exp. Date 12/06/2020 (19 kits) AGDB14J
Lot # 737191
Exp. Date 09/20/2020 (2 kits) AHLA17J
Lot # 653191
Exp. Date 12/13/2020 (12 kits) SVNE16K
Lot # 691191
Exp. Date 11/05/2020 (20 kits) WPLA17I
Lot # 685191
Exp. Date 11/11/2020 (2 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 from 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 · regulatory non compliance