Recall Z-1367-2018 ยท BTC Bag, Reservoir
Teleflex Medical Europe Ltd
Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 (b) 153000005 153000005 (c) 153000010 153000010 (d) 153000020 153000020 (e) 153000030 153000030 (f) 153000050 153000050 (g) 210700050 2107050 (h) 210700102 2107102 (I) 210700202 2107202 (j) 210700302 2107302 (k) 210700402 2107402 (l) 210700502 2107502 (m) 210700602 2107602 Product Usage: Rebreathing Bag is indicated for man
| Date | Apr 12, 2018 (initiated Mar 15, 2018) |
| Status | Terminated |
| Reason | These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. |
| Root cause | Employee error |
| Action | The firm initiated their field correction on 03/15/2018 by letter. The notices stated the following: Affected distributors are instructed to take the following actions: 1. Place a copy of this notification with each unit of affected product currently in your inventory. 2. Using the provided customer letter template and acknowledgment form, communicate this notification to any of your customers who have received product included within the scope of this notification. 3. Have each of your customers who received the affected product return a completed acknowledgment form to you. 4. Once you have |
| Quantity | 107962 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.