CELSITE BabyPort sets recalled over potential vessel damage or tearing
CELSITE BabyPort Set PUR 4.5F IV, catalog 5433742, lot 37041185, is recalled because of the potential for minor injury such as damage to the vessel and/or tearing of the vessel wall. 58 units are affected.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; the notice describes potential vessel damage or tearing and reports no injuries.
Plain-English summary
The CELSITE BabyPort Set PUR 4,5F IV USA, model and catalog number 5433742, primary DI 04046963594947, lot 37041185 with an expiry of 19MAR2030, is being recalled. The recall covers 58 units distributed in Pennsylvania.
The recall was issued because of the potential for minor injury such as damage to the vessel and/or tearing of the vessel wall. The FDA classified the action as Class II.
Hospitals holding this lot should quarantine it and follow the manufacturer's instructions for return or replacement.
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.
- Category
- Medical Device — Vascular Access
- Affected units
- 58
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
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