B. Braun Stopcock Extension Sets Recalled for Reverse Assembly Defect
B. Braun Medical is recalling 10,835 Stopcock Extension Sets because some stopcocks are assembled in reverse, causing them to close when set to open.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a functional failure of a medical device that could lead to harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
B. Braun Medical, Inc. is recalling 10,835 units of Stopcock Extension Sets with 3-Way Stopcock with Injection Site and Spinlock Connector. The affected products are 22 inches and 37 inches in length. The recall covers product codes 473547 and 473549 with lot numbers 61356774, 61362114, and 61367665, and expiration dates ranging from January 31, 2019, to March 31, 2019.
The recall was initiated after complaints reported that the stopcock on some units is assembled in the reverse position. This defect results in the stopcock being closed when the device is set to the open position, and vice versa. The products were distributed nationwide in the United States, including Pennsylvania, Illinois, North Carolina, Florida, California, Colorado, Nebraska, Louisiana, Virginia, Tennessee, Texas, and Kansas.
Healthcare facilities and consumers should stop using the affected Stopcock Extension Sets immediately. Users should check their inventory for the specific product codes and lot numbers listed above. B. Braun Medical, Inc. is the recalling firm responsible for this action.
The recalled product
- Product
- STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 10,835
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Product codes: 473547 and 473549 lot #s and expiration dates: 61356774
- 1/31/2019
- 61362114
- 2/28/2019
- and 61367665
- 3/31/2019.
Distribution
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