Arrow Select Kits Recalled Due to Potential Sterility Compromise
Arrow International is recalling Select Kits and Maximal Barrier Precautions Kits containing BD Posiflush syringes because open seals may compromise sterility.
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 potential loss of sterility in a medical device, which poses a risk of harm (infection) even though no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Arrow International Inc. is recalling Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) that include BD Medical Posiflush 10mL Saline Flush Syringes. The recall involves 71,255 units distributed nationwide.
The recall was initiated because the component supplier identified that some unit packages may exhibit open seals. This defect impacts package integrity and potentially compromises the sterility of the 0.9% Sodium Chloride Injection USP BD Posiflush SF Saline Flush Syringe 10mL.
Healthcare facilities and consumers should check their inventory for the specific product numbers and lot numbers listed in the official recall notice. If the affected products are found, they should be removed from use and returned to the supplier or disposed of according to local regulations.
The recalled product
- Product
- Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.
- Manufacturer
- Arrow International Inc
- Affected units
- 71,255
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)
- Product Numbers: ASK-04001-VCUH
- ASK-04510-MM3
- ASK-05001-TSC
- ASK-05052-QV
- ASK-05052-SFL
- ASK-05502-UWMC
- ASK-05541-MS2
- ASK-09804-SPH
- ASK-09810-PCMH1
- ASK-09903-ECL
- ASK-09903-PCMH1
- ASK-11142-MGH3
- ASK-12703-MGH2
- ASK-12703-SPH
- ASK-15703-MH
- ASK-15854-FAM ASK-17702-PJHH1
- ASK-21142-HF2
- ASK-21242-PCMH1
- ASK-21242-SFM1
- ASK-21242-UVA3
Distribution
Distributed nationwide across the United States.
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