Z-1531-2013 Class II Terminated
FDA device recall Z-1531-2013 was initiated by International Biomedical, Ltd. on May 24, 2013 and is designated Class II. Reason for recall: International Biomedical has received reports of interference between the collection bag and the extension set connectors. Evaluation of the affected components indicates that the collection bag conne… The recall status is terminated (terminated July 29, 2013). Affected quantity: 7,000.
Recall Details
- Product Type
- Devices
- Report Date
- June 19, 2013
- Initiation Date
- May 24, 2013
- Termination Date
- July 29, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,000
Product Description
VIA Medical Collection Bag; The collection bag is an accessory waste bag used in conjunction with the sterile LVM blood gas sensor with the LVM Monitor. The collection bag is packaged in a tyvek pouch which is included in either replacement kit (777-3103) or LVM sensor kit (777-3102).
Reason for Recall
International Biomedical has received reports of interference between the collection bag and the extension set connectors. Evaluation of the affected components indicates that the collection bag connector can become occluded due to an over-tightening of the luer lock by the end user. To alleviate the occurrence of this issue in the fixture, the connector on the collection bag has been improved to
Distribution Pattern
Nationwide Distribution.
Code Information
Model/Part Number: 209-2113, or as part of kits 777-3103 and 777-3102. Collection Bag Lot numbers: 4389, 4465, 4478, 4516, 4530, 4430, 4489