B. Braun Recalls SAFSITE Injection Sites and IV Sets Due to Leakage
B. Braun Medical is recalling specific lots of SAFSITE Injection Sites and IV Sets because complaints reported leakage. The devices are used for needle-free access on IV and extension sets.
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 involves a medical device defect (leakage) that poses a risk of harm to patients, but the source text does not report any injuries or illnesses, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
B. Braun Medical, Inc. is recalling 2,357,944 units of SAFSITE Injection Sites and IV Sets manufactured with SAFSITE Injection Sites. These devices are used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein, and the SAFSITE Injection Site is intended to provide needle-free access on IV and extension sets.
The recall was initiated after complaints were received reporting leakage on certain lots of the affected products. The source text does not specify the number of complaints, the nature of the leakage, or any reported injuries or illnesses associated with the defect.
The affected products were distributed nationwide. Consumers and healthcare facilities should check their inventory for the specific catalog numbers, batch numbers, and expiration dates listed in the recall notice. If the products match the affected lots, they should be removed from use and returned to B. Braun Medical, Inc. according to the firm's instructions.
The recalled product
- Product
- SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites. A device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- Affected units
- 2,357,944
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 (20)
- Catalog #351559: batch #s 0061339694
- exp. 9/30/2018
- 0061338909
- 0061333582
- exp. 8/31/2018
- catalog # 352016
- batch # 0061326956
- exp. 10/31/2018
- catalog # 352079
- batch #0061333591
- catalog #352448
- batch # 0061334116
- exp.9/30/2018
- catalog #473017
- batch #0061332459
- catalog # 473017
- batch #061335025
- catalog #473309
- batch #s 0061343285
- calatog #473309
Distribution
Distributed nationwide across the United States.
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