5/10 Weck¿ Vista" Universal Balloon Open Access Port - Long Length (100mm), 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.
Reported: April 2, 2014 Initiated: March 11, 2014 #Z-1287-2014
Product Description
5/10 Weck¿ Vista" Universal Balloon Open Access Port - Long Length (100mm), 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.
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.
Details
- Recalling Firm
- Teleflex Medical
- Units Affected
- 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.
- Location
- Research Triangle Park, NC
Frequently Asked Questions
What product was recalled? ▼
5/10 Weck¿ Vista" Universal Balloon Open Access Port - Long Length (100mm), 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.. Recalled by Teleflex Medical. Units affected: 55,521 ea. in total.
Why was this product recalled? ▼
Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 2, 2014. Severity: Moderate. Recall number: Z-1287-2014.
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