Z-2166-2020Class II

Sterile Custom Packs to be used in surgical procedures

Name: Z-2166-2020 Sterile Custom Packs to be used in surgical procedures
Creator: American Contract Systems
Published: 2020-04-13
License: https://open.fda.gov/license/

American Contract Systems, Inc. / initiated 2020-04-13 / Terminated / root cause: manufacturing process

FDA source

American Contract Systems began a recall of Sterile Custom Packs to be used in surgical procedures on 2020-04-13. FDA classified it as Class II and gives the reason as "The surgical gowns were manufactured in a facility that is not registered by the FDA". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2166-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-13
Posted: 2020-05-29
Terminated: 2020-11-25
Recalling firm: American Contract Systems, Inc.
Product: Sterile Custom Packs to be used in surgical procedures.
Product code: LRO General Surgery Tray
Reason for recall: The surgical gowns were manufactured in a facility that is not registered by the FDA.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Notification to the distributor and instructed them to notify its customers (hospitals) of the recall and product removal.
Quantity in commerce: 2,868 surgical kits total
Distribution: US Nationwide distribution including in the state of Pennsylvania.
Product codes and lots: ACS Tray Numbers: SVOH98F; Lot # 676191, Exp. date 11/20/20 (3 kits) AHMV261; Lot # 676191, Exp. date 11/20/20 (10 kits) AGMV26L: Lot # 688191, Exp. date 11/08/2020 (36 kits) FBTO60G: Lot # 635191, Exp. date 12/31/2020 (25 kits) FBTO60G: Lot # 711191, Exp. date 10/16/2020 (3 kits) AGEP48G: Lot # 991201, Exp. date 01/09/2021 (72 kits) AGBR90D: Lot # 843191, Exp. date 06/06/2020 (48 kits) AGTP52J: Lot # 643191, Exp. date 12/23/2020 (42 kits) AGTP52J: Lot # 716191, Exp. date 10/11/2020 (8 kits)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2166-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2166-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-05-29
Z-2167-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-05-29
Z-2168-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-05-29
Z-2169-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-05-29
Z-2170-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-05-29
Z-2171-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-05-29
Z-2172-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-05-29
Z-2173-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-05-29
Z-2174-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-05-29
Z-2175-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-05-29
Z-2176-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-05-29
Z-2177-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-05-29
Z-2178-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-05-29
Z-2179-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-05-29

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)