CLASS II Device recall · Reported 10 Jun 2020 · FDA Enforcement Report

Sterile Custom Packs to be used in surgical procedures recalled

American Contract Systems is recalling Sterile Custom Packs to be used in surgical procedures, distributed nationwide in the US. The recall was initiated on 13 Apr 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesACS Tray Numbers: AGPP38I; Lot # 644191, Exp. Date 12/22/2020 (2 kits) and Lot # 713191, Exp. Date 10/14/2020 (12 kits) AGHA64J; Lot # 663191, Exp. Date 12/03/2020 (72 kits) and Lot # 716191, Exp. Date 10/11/2020 (10 kits) WPBU64H; Lot # 670191, Exp. Date 11/26/2020 (16 kits)

Quantity recalled2, 868 total kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2178-2020
FDA event ID: 85502
Recalling firm: American Contract Systems, Zelienople, PA
Classification: Class II
Status: Terminated
Recall initiated: 13 Apr 2020
FDA classified: 29 May 2020
Reported: 10 Jun 2020
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Sterility
Device type: Surgical Instruments

Timeline

13 Apr 2020	Recall initiated by company
29 May 2020	Classified by FDA	+46 days
10 Jun 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The surgical gowns were manufactured in a facility that is not registered by the FDA.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Sterile Custom Packs to be used in surgical procedures.

Where it was distributed

US Nationwide distribution including in the state of Pennsylvania.

Nationwide Pennsylvania

Questions about this recall

Is Sterile Custom Packs to be used in surgical procedures recalled?

Yes. American Contract Systems recalled Sterile Custom Packs to be used in surgical procedures on 13 Apr 2020. The recall is Class II and its status is Terminated. Recall number Z-2178-2020.

Why was it recalled?

The surgical gowns were manufactured in a facility that is not registered by the FDA.

Which lots are affected?

ACS Tray Numbers: AGPP38I; Lot # 644191, Exp. Date 12/22/2020 (2 kits) and Lot # 713191, Exp. Date 10/14/2020 (12 kits) AGHA64J; Lot # 663191, Exp. Date 12/03/2020 (72 kits) and Lot # 716191, Exp. Date 10/11/2020 (10 kits) WPBU64H; Lot # 670191, Exp. Date 11/26/2020 (16 kits)

Where was it sold?

US Nationwide distribution including in the state of Pennsylvania.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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2 Sep 2026Device	CLASS II	Convenience Kit, CV B PACK recalled by American Contract Systems	American Contract Systems	Foreign Material	Nationwide
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