Z-1289-2014Class II

5/10/12 Weck Vista" Universal Balloon Open Access Port Standard Length (70mm)

Name: Z-1289-2014 5/10/12 Weck Vista" Universal Balloon Open Access Port Standard Length (70mm)
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 5/10/12 Weck Vista" Universal Balloon Open Access Port Standard Length (70mm), Product Usage: An endoscope and accessories is a device used to provide access... on 2014-03-11. FDA classified it as Class II and gives the reason as "Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures". 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-1289-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-11
Posted: 2014-03-25
Terminated: 2017-08-15
Recalling firm: Teleflex Medical
Product: 5/10/12 Weck Vista" Universal Balloon Open Access Port Standard Length (70mm), Product Usage: 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 were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Teleflex sent an Urgent Medical Device Recall Notification letter dated March 11, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to return all affected product to Teleflex Medical per the instructions provided in the letter. Customers were asked to complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service. For questions contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in commerce: 55,521 ea. in total
Distribution: Worldwide Distribution - USA Nationwide including Puerto Rica and the countries of: Australia, Brazil, China, Canada, Malaysia, Korea, Ireland Singapore and Vietnam.
Product codes and lots: Product Code: 410944S, Lot Numbers: 01J1200460, 01K1200619, 01L1200515, and 01E1300137.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1289-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1276-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-25
Z-1277-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-25
Z-1278-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-25
Z-1279-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-25
Z-1280-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-25
Z-1281-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-25
Z-1282-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-25
Z-1283-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-25
Z-1284-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-25
Z-1285-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-25
Z-1286-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-25
Z-1287-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-25
Z-1288-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-25
Z-1289-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-25
Z-1290-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-25

Product code GCJ

K112456Class IIAdapt(tm) Universal Balloon Open Access PortTeleflexmedical, Inc. / cleared 2011-10-04

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)