Z-1193-2018Class II

Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations

Name: Z-1193-2018 Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations
Creator: Teleflex Medical
Published: 2018-02-15
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2018-02-15 / Terminated / root cause: packaging

FDA source

Teleflex Medical began a recall of Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations on 2018-02-15. FDA classified it as Class II and gives the reason as "Some boxes are labeled as Visistat Wide devices, when in fact the contain Visistat Regular devices. The 6 individually packaged units within the boxes are correctly labeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1193-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-15
Posted: 2018-03-26
Terminated: 2018-10-31
Recalling firm: Teleflex Medical
Product: Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations.
Product code: GDT Staple, Removable (Skin)
Reason for recall: Some boxes are labeled as Visistat Wide devices, when in fact the contain Visistat Regular devices. The 6 individually packaged units within the boxes are correctly labeled.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: The firm initiated the recall on 02/14/2018 by letter and followed up with another letter on 03/12/2018 to clarify the labeling issue. The letter to the distributor stated: "1. Immediately discontinue distribution and quarantine any products with the catalog and lot number listed above. 2. Inspect affected products within your control to identify if the box label correctly identifies the products inside the box. Products with an incorrect label on the box should be returned to Teleflex Medical so that they are not distributed to health care providers in error. 3. Using the provided Customer Letter and Acknowledgement Form templates, communicate this recall to any of your customers who have received product included within the scope of the recall. Customers may return mislabeled products if they choose to do so. Note the attached Customer Letter template was updated since this letter was first sent to you. 4. If any of your customers wish to return affected products, have them return the affected products to you, together with a completed Acknowledgement Form, for consolidation and return to Teleflex Medical. In the event that an alternative approach is needed, contact Teleflex Customer Service for more information at 1-866-246-6990." The customer letter requested discontinuation of use and quarantining of products and return of affected stock.
Quantity in commerce: 12 units
Distribution: KS
Product codes and lots: Lot Number 73H1600207

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1193-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1193-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-26

Product code GDT

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)