Recall Z-1906-2016 ยท LHI Set, I.V. Fluid Transfer
B. Braun Medical, Inc.
Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve Product Usage: Used for aspiration of medication from inverted bags or semi-rigid containers. Interavenous delivery of transferred medication(Device is not intended for direct infusion)
| Date | Jun 2, 2016 (initiated Apr 14, 2016) |
| Status | Terminated |
| Reason | BBMI recently identified a potential for a tear in the outer blister packaging on a limited number of units. The tears have been identified in the blister package paper, where the unit label writing is located. |
| Root cause | Process control |
| Action | B. Braun notified customers via letter to inform them of the reason for the recall, the risks and affected lots involved were identified and customers were asked to discontinue use of the product and complete the Product Removal Acknowledgement form and return to B. Braun Medical Inc. Quality Assurance department by faxing it to (610)849-1197 or e-mail to: PA_QualityAssurance.BBMUS_Service@bbraun.com and a BBMI Customer Support Representative will contact the consignee to provide instructions for handling the affected product and arrange for its return to BBMI. |
| Quantity | Approximately 11,000 units available in commercial channels |
| Distribution | US Nationwide Distribution in the states of: AL, AR, AZ, BC, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN. TX, UT, VA, VT, WA, WI, WV and Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K943181 | DISPENSING PIN WITH ONE-WAY VALVE B. Braun of America, Inc., Sep 29, 1994 |