RecallRadar

FDA Device recall Z-0066-2015

Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe

On 2014-10-22 the FDA classified a Class II recall of Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe by Arrow International, citing the component supplier recalled their 0.9% Sodium Chloride Injection USP BD Posiflush SF Saline Flush Syringe 10mL because some unit packages may exhibit open seals which impact p….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0066-2015
ClassificationClass II
Statusterminated
Initiated2014-08-06
Published2014-10-22
Last updated2026-09-13 11:53 UTC
CompanyArrow International
DistributionUS

Product

Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.

Reason

The component supplier recalled their 0.9% Sodium Chloride Injection USP BD Posiflush SF Saline Flush Syringe 10mL because some unit packages may exhibit open seals which impact package integrity and potentially product sterility.

Identifiers

code_info
Product Numbers: ASK-04001-VCUH, ASK-04510-MM3, ASK-05001-TSC, ASK-05052-QV, ASK-05052-SFL, ASK-05502-UWMC, ASK-05541-M…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, ASK-29803-HF3, ASK-29803-MM, ASK-29803-MS, ASK-29903-UK, ASK-29903-UK, ASK-34041-PTG, ASK-34052-PTG, ASK-35052-PTG, ASK-42703-AMC, ASK-42703-OHU1, ASK-42703-PCCH1, ASK-42703-PCSJ, ASK-42703-PPMC, ASK-42703-PSBM, ASK-42703-PSCH, ASK-42703-PSFM, ASK-42703-PTRH, ASK-42703-SJMT, ASK-42703-UHC, ASK-42802-ECL1, ASK-42802-PMCG, ASK-42802-PUCS, ASK-42854-CMC2, ASK-45703-MM2, ASK-45703-NYU1, ASK-45703-PCCH1, ASK-45703-PCHS1, ASK-45703-PCSJ, ASK-45703-PDCH, ASK-45703-PGBM1, ASK-45703-PHCH, ASK-45703-PHF, ASK-45703-PHF1, ASK-45703-PHPA2, ASK-45703-PIA, ASK-45703-PLGH1, ASK-45703-PMHG, ASK-45703-PSA, ASK-45703-PTMC, ASK-45703-PUAB, ASK-45703-PUC ASK-45703-P

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0066-2015%22

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