Z-0066-2015Class II

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

Name: Z-0066-2015 Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline...
Creator: Arrow International Inc
Published: 2014-08-06
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2014-08-06 / Terminated / root cause: packaging

FDA source

Arrow International Inc began a recall of Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe on 2014-08-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0066-2015
Classification: Class II
Status: Terminated
Initiated: 2014-08-06
Posted: 2014-10-14
Terminated: 2016-10-14
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.
Product code: DQY Catheter, Percutaneous
Reason for recall: 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.
Root cause tag: packaging
FDA root cause: Packaging
Action: Arrow International sent an Urgent Medical Device Recall Notification letter, dated August 6, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine any affected product. Customers were instructed to remove the BD pre-filled saline syringe from the exterior of the packaging. To return the BD syringes, customers were instructed to complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service. A customer service representative will contact the customer with a Return Good Authorization (RGA) Number and will provide instructions for the return of producet to Arrow International. All customers were asked to complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507. Attn: Customer Service. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-866-246-6990.
Quantity in commerce: 71255
Distribution: Nationwide Distribution
Product codes and lots: 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-PUHC, ASK-45703-PUR, ASK-45703-PVCU, ASK-45703-UHC, ASK-45703-UKM, ASK-45802-PCMH1, ASK-45854-NG, ASK-45854-PCHS1, ASK-45854-PECL, CDC-02041-MK1A, CDC-05041-HPK1A, CDC-05052-HPK1A, CDC-21242-X1A, CDC-24703-X1A, CDC-25123-X1A, CDC-25402-X1A, CDC-25502-X1A, CDC-25553-X1A, CDC-26553-X1A, CDC-29803-X1A, CDC-29903-X1A CDC-34052-HPK1A, CDC-35041-VPS, CDC-35052-HPK1A, CDC-35052-VPS, CDC-35063-VPS, CDC-35563-VPS, CDC-42703-XP1A, CDC-42802-XP1A, CDC-42802-XP1A, CDC-44041-HPK1A, CDC-44052-HPK1A, CDC-45041-HPK1A, CDC-45041-VPS, CDC-45541-HPK1A, CDC-45541-VPS, CDC-45552-HPK1A, CDC-45703-XP1A, CDC-45703-XPB1A, CDC-45802-XP1A, CDC-45854-XP1A, CDC-46702-XP1A, with lot numbers: 23F13H1030, 23F13H0046,RF3053077, 23F13J0406, 23F13H0230, 23F13J0435, 23F13J0440, 23F13H1031, 23F13J0181, 23F13G0409, 23F13H0060, 23F13H0231, RF3053088, 23F13H0232, 23F13H0062, 23F13H0233, RF3053092, RF3053096, 23F13J0072, 23F13H0520, 23F13H1032, 23F13H0064, 23F13J0446, 23F13H0804, 23F13J0187, 23F13H0069, 23F13J0193, 23F13H1033, 23F13G0724, 23F13H0898, RF3053035, 23F13J0202, 23F13H0297, RF3053111, 23F13H0521, 23F13G0402, 23F13G0404, 23F13H1034, 23F13G0495, 23F13J0399, 23F13H0072, 23F13H0808, 23F13H0810, 23F13H0313, RF3053655, 23F13J0208, 23F13H0315, 23F13H0768, 23F13J0254, RF3052973, 23F13J0204, 23F13J0037, 23F13J0352, 23F13J0207, 23F13H0687, 23F13H0512, 23F13J0349, 23F13J0452, RF3040503, 23F13G0472, RF3052873, 23F13J0400, 23F13J0401, 23F13H0816, 23F13H0817, 23F13H0818, 23F13J0241, 23F13H0451, 23F13H0861, 23F13H0858, 23F13H0819, 23F13G0830, 23F13H0519, 23F13H0821, 23F13J0351, 23F13G0473, 23F13J0217, 23F13J0073, RF3065022, 23F13H0045, 23F13H0916, 23F13H0796, 23F13J0403, 23F13J0542, 23F13H0127, 23F13J0454, 23F13J0057, 23F13J0291, 23F13J0080, 23F13J0076, 23F13H0994, 23F13H0013, 23F13H0993, 23F13H0022, RF3064650, 23F13H0919, 23F13J0160, 23F13H1018, 23F13J0162, 23F13J0166, 23F13H0911, RF3052890, 23F13J0167, RF3052884, RF3052536, RF3041482, 23F13J0178, RF3054066, 23F13J0135, 23F13J0014, 23F13H0349, 23F13H0351, 23F13H0266, 23F13H0036, 23F13H0265, 23F13H0707, 23F13H0709, 23F13H0941, 23F13J0319, 23F13J0133, 23F13J0390, 23F13J0137, 23F13G0578, 23F13J0331, 23F13H0750, 23F13H0267, 23F13H0752, 23F13H0753, 23F13J0304, 23F13J0298, 23F13J0301, 23F13H0751, 23F13J0303, 23F13G0217, 23F13H0268, 23F13H0269, 23F13H0270, RF3052159, RF3054123, RF3054125, 23F13H0759, 23F13J0249, 23F13H0668, 23F13H0664, 23F13H0706.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0066-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0066-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-22	2014-10-14

Product code DQY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)