Z-1599-2018Class II

6381 M-1 Cot Fastener, catalog no. 6381000000

Name: Z-1599-2018 6381 M-1 Cot Fastener, catalog no. 6381000000
Creator: Stryker Medical Division of Stryker Corporation
Published: 2018-03-09
License: https://open.fda.gov/license/

Stryker Medical / initiated 2018-03-09 / Terminated / root cause: labeling and UDI

FDA source

Stryker Medical Division of Stryker Corporation began a recall of 6381 M-1 Cot Fastener, catalog no. 6381000000 on 2018-03-09. FDA classified it as Class II and gives the reason as "The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1599-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-09
Posted: 2018-05-02
Terminated: 2019-04-09
Recalling firm: Stryker Medical
Product: 6381 M-1 Cot Fastener, catalog no. 6381000000
Product code: FPO Stretcher, Wheeled
Reason for recall: The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On March 9, 2018, the recalling firm notified affected distributors of the issue via their electronic product field action management system, who in turn notified their customers through written communication. Customers were informed of the issue and instructed to do the following: 1. Locate the operations manual shipped with each unit listed on the attached business reply form and replace it with the corrected manual included with the letter. Dispose of the incorrect manual. 2. Return the enclosed business reply form to confirm receipt of this notification to [email protected] 3. If you have loaned or sold any of the products listed in this letter, please forward a copy of this notice to the new users and advise the firm of their new location in the space provided on the business reply form. 4. If you have disposed of any of these units, advise the firm of their obsolescence by providing the firm with their serial number in the space provided on the business reply form.
Quantity in commerce: 3
Distribution: Product distributed to the Netherlands
Product codes and lots: Serial No. 170740538 170740539 170740540

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1599-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1598-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-05-02
Z-1599-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-05-02

Product code FPO

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)