Z-1566-2013 Class II Terminated
FDA device recall Z-1566-2013 was initiated by Loma Vista Medical on March 18, 2013 and is designated Class II. Reason for recall: Slow deflation time: Slower than normal balloon deflation time of greater than 10 seconds. The balloon normally deflates in less than 5 seconds. The device performance specification for deflation ti… The recall status is terminated (terminated July 17, 2013). Affected quantity: 2379 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 3, 2013
- Initiation Date
- March 18, 2013
- Termination Date
- July 17, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2379 units
Product Description
TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02245-12, 02445-12, and 02645-13; Sizes: 20mm x 4.5cm, 22mm x 4.5cm, 24mm x 4.5cm, and 26mm x 4.5cm; Intended to be used for balloon aortic valvuloplasty.
Reason for Recall
Slow deflation time: Slower than normal balloon deflation time of greater than 10 seconds. The balloon normally deflates in less than 5 seconds. The device performance specification for deflation time is 10 seconds maximum.
Distribution Pattern
Worldwide Distribution-US Distribution in New Jersey and the countries of Germany, Switzerland, Italy, Norway, The Netherlands, Spain, Portugal, Ireland, and Austria.
Code Information
All lot numbers lower than PLN00749 are subject to this recall.