The Recall Desk
HighFDA (Devices)·Z-0066-2015·Announced 2014-10-22

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.

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: 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
Category
Medical Device — IV Catheter Kits
Hazard
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.

Related recalls

Same manufacturer · Arrow International Inc

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Same hazard · sterility compromise

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