B.Braun CELSITE IV Port Sets Recalled for Vessel Damage Risk
B.Braun is recalling 58 units of CELSITE BABYPORT IV port sets (Lot 37041185) due to potential vessel damage or tearing. The defective units were distributed in Pennsylvania.
What this means for you
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: FDA Class II recall of a vascular access device with potential for patient harm. No illnesses or injuries have been reported, but the product poses a risk-of-harm, warranting a High severity classification per the rubric criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
B.Braun Medical S.A.S. is recalling 58 units of CELSITE BABYPORT SET PUR 4,5F IV port sets (Catalog Number 5433742, Lot 37041185, expiration date March 19, 2030). This is an intravenous vascular access port set.
The recall was initiated due to a potential manufacturing defect that poses a risk for minor injury. Specifically, the defect could cause damage to the blood vessel and/or tearing of the vessel wall.
The recalled units were distributed in Pennsylvania. Healthcare facilities and medical professionals who received these devices should verify their inventory using the lot number and implement appropriate measures to prevent use of affected units. Patients should be aware of this recall and inform their healthcare provider of any concerns.
The recalled product
- Product
- Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software Version: N/A Product Description: CELSITE BABYPORT SET PUR 4,5F IV USA Component: N/A
- Manufacturer
- B.Braun Medical S.A.S.
- Hazard
- vessel-damage
- vessel-tearing
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 (4)
- Model/Catalog Number: 5433742
- Primary-DI 04046963594947
- Lot 37041185
- Exp 19MAR2030
Distribution
Distributed nationwide across the United States.
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