Recall Z-1164-2008 ยท BTC Bag, Reservoir
Medline Industries Inc
2 Liter Latex-Free Breathing Bag; Reservoir Bag; Vendor Part Number: 720058B, Medline Item Number: 40054; Available in various Anesthesia Circuit Kits and Complete Delivery System Kits including: 1) Item Number CDS980652A, Thoracic Anesthesia Pack; 2) Item Number CDS980955, Affinity Shoulder Arthroscopy; 3) Item Number CDS980956, Affinity Total Hip CDS; 4) Item Number CDS980957, Affinity Total Kne
| Date | Jun 25, 2008 (initiated Dec 7, 2007) |
| Status | Terminated |
| Reason | Separation from Bushing: The breathing bag may separate from the bushing during use. |
| Root cause | Device Design |
| Action | Consignees were notified by a Sub-Recall Notice letter sent on 12/5/07. The letter instructed users to check their inventory for any affected product and to return a response card indicating the quantity of affected product. The users were instructed to return the affected products to the recalling firm so that they can be reworked. Users who did not wish to return the affected products could request a replacement product and were instructed to destroy the affected products. The letter also informed users that affected products in the manufacturer's inventory were being replaced and these |
| Quantity | 57,000 bags |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.