Z-1906-2016Class II

Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve

Name: Z-1906-2016 Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve
Creator: B. Braun Medical, Inc.
Published: 2016-04-14
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2016-04-14 / Terminated / root cause: manufacturing process

FDA source

B. Braun Medical, Inc. began a recall of 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... on 2016-04-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1906-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-14
Posted: 2016-06-02
Terminated: 2017-03-13
Recalling firm: B Braun Medical Inc
Product: 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)
Product code: LHI Set, I.V. Fluid Transfer
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.
Root cause tag: manufacturing process
FDA 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: [email protected] 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: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1906-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1906-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-06-02
Z-1907-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-06-02

Product code LHI

K943181Class IIDispensing Pin with One-Way ValveB. Braun of America, Inc. / cleared 1994-09-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)