Class 2 Device Recall Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC)

• Date Initiated by Firm: August 06, 2014
• Date Posted: October 14, 2014
• Recall Status: Terminated on October 14, 2016
• Recall Number: Z-0066-2015
• Recall Event ID: 68987
• 510(K)Number: K011761 K073451 K780532 K810675 K862056
• Product Classification: Catheter, percutaneous - Product Code DQY
• Product: Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.
• Code Information: 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.
• Recalling Firm/ Manufacturer: Arrow International Inc; 2400 Bernville Rd; Reading PA 19605-9607
• For Additional Information Contact: Customer Support; 610-378-0131
• Manufacturer 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.
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DQY; 510(K)s with Product Code = DQY