Z-1324-2014Class II

10mm Weck Vista Cannula-only, Catalog No. 405910C, 12mm Weck Vista Cannula-only, Catalog No. 405912C. An...

Name: Z-1324-2014 10mm Weck Vista Cannula-only, Catalog No. 405910C, 12mm Weck Vista Cannula-only, Catalog No. 405912C. An...
Creator: Teleflex Medical
Published: 2014-03-11
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2014-03-11 / Terminated / root cause: manufacturing process

FDA source

Teleflex Medical began a recall of 10mm Weck Vista Cannula-only, Catalog No. 405910C, 12mm Weck Vista Cannula-only, Catalog No. 405912C. An endoscope and accessories is a device used to provide... on 2014-03-11. FDA classified it as Class II and gives the reason as "Complaints of leakage of insufflation gas through the device". 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-1324-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-11
Posted: 2014-04-02
Terminated: 2016-01-28
Recalling firm: Teleflex Medical
Product: 10mm Weck Vista Cannula-only, Catalog No. 405910C, 12mm Weck Vista Cannula-only, Catalog No. 405912C. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: Complaints of leakage of insufflation gas through the device.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Letters were issued on March 11, 2014 to customers informing them of the recall. The letter asked the consignee to immediately discontinue use and quarantine any products on hand. The letter included a Recall Acknowledgement Form which is to be returned. A letter was also issued to distributors on March 11, 2014, requesting them to conduct a sub-recall.
Quantity in commerce: 55,521 total
Distribution: Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, MD, MA, MI, MN, MS, MO, NH, NJ, NY, NC, ND, OH, OR, PA, SC, TN, UT, VA, WA, WV, WI and the countries of Australia, Brazil, Canada, China, Israel, Korea, Malaysia, Singapore, and Vietnam.
Product codes and lots: Lots - Catalog No. 405910C - 01G1200243, 01J1200226, 01L1200368, 01A1300177, 01D1300107, 01E1300140, 01E1300435, Catalog No. 405912C - 01J1200384, 01K1200725, 01L1200352, 01D1300319

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1324-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1323-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-09	2014-04-02
Z-1324-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-09	2014-04-02
Z-1325-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-09	2014-04-02
Z-1326-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-09	2014-04-02
Z-1327-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-09	2014-04-02
Z-1328-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-09	2014-04-02

Product code GCJ

K121796Class IIWeck Reusable ObturatorTeleflexmedical, Inc. / cleared 2012-10-11

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)