Z-1696-2022Class II

Various Port Insertion Packs

Name: Z-1696-2022 Various Port Insertion Packs
Creator: American Contract Systems, Inc.
Published: 2022-06-16
License: https://open.fda.gov/license/

American Contract Systems, Inc. / initiated 2022-06-16 / Open, Classified / root cause: sterility

FDA source

American Contract Systems, Inc. began a recall of Various Port Insertion Packs on 2022-06-16. FDA classified it as Class II and gives the reason as "Product was exposed to multiple sterilization cycles without validation for multiple exposures". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1696-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-16
Posted: 2022-09-08
Recalling firm: American Contract Systems, Inc.
Product: Various Port Insertion Packs
Product code: OKE Port Introducer Kit
Reason for recall: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Root cause tag: sterility
FDA root cause: Process change control
Action: The recalling firm began notifying customers of the recall beginning June 13, 2022. Customer notification was initially made via email and an "Urgent Medical Device Recall" letter dated June 16, 2022. Customers are asked to review inventory and segregate affected product, which should be identified with the Bag Serial Number. Affected product should be destroyed, with evidence of destruction provided back to the recalling firm. A Field Action Response Form should be completed and returned to [email protected] as soon as possible, even if the customer has no inventory. If you have any questions, please call 816-920-5846.
Quantity in commerce: 2 units
Distribution: Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX
Product codes and lots: Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) GSPI26E, 2108202, 770211, 44336884-005 2) GSPI26E, 2108202, 770211, 44336909-005

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1696-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1689-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-14	2022-09-08
Z-1690-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-14	2022-09-08
Z-1691-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-14	2022-09-08
Z-1692-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-14	2022-09-08
Z-1693-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-14	2022-09-08
Z-1694-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-14	2022-09-08
Z-1695-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-14	2022-09-08
Z-1696-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-14	2022-09-08
Z-1697-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-14	2022-09-08
Z-1698-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-14	2022-09-08
Z-1699-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-14	2022-09-08
Z-1700-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-14	2022-09-08
Z-1701-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-14	2022-09-08
Z-1702-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-14	2022-09-08
Z-1703-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-14	2022-09-08
Z-1704-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-14	2022-09-08
Z-1705-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-14	2022-09-08

Product code OKE

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)