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U.S. Department of Health and Human Services

Class 2 Device Recall NonVented Dispensing Pin

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  Class 2 Device Recall NonVented Dispensing Pin see related information
Date Initiated by Firm April 14, 2016
Date Posted June 02, 2016
Recall Status1 Terminated 3 on March 13, 2017
Recall Number Z-1907-2016
Recall Event ID 73986
510(K)Number K943181  
Product Classification Set, i.V. Fluid transfer - Product Code LHI
Product Non-Vented Dispensing Pin with 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)
Code Information Serial Numbers: 61342856, 61181826, 61200666, 61221679, 61250908, 61230098, 61259709, 61316886, 61325854, 61318424, 61321589, 61315864, 61187901, 61282829, 61247686, 61266076, 61277092 Product Catalog Number: 412023 and 412027
Recalling Firm/
Manufacturer		 B. Braun Medical, Inc.
901 Marcon Blvd
Allentown PA 18109-9512
For Additional Information Contact Robert P. Hubert
610-596-2870
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 in Commerce 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LHI and Original Applicant = B. BRAUN OF AMERICA, INC.
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