{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "156669", "product_res_number": "Z-0179-2018", "event_date_initiated": "2017-06-01", "event_date_created": "2017-11-28", "recall_status": "Terminated", "event_date_terminated": "2020-04-13", "res_event_number": "77589", "product_code": "OBJ", "k_numbers": [ "K103255" ], "product_description": "Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter\nThe intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which is to the cavo-atrial junction near the sino-atrial node", "code_info": "Lot/Batch Numbers: 23F16M0017", "firm_fei_number": "3015859709", "recalling_firm": "Arrow International Inc", "address_1": "2400 Bernville Rd", "city": "Reading", "state": "PA", "postal_code": "19605-9607", "additional_info_contact": "Customer Service\n866-246-6990", "reason_for_recall": "There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.", "root_cause_description": "Mixed-up of materials/components", "action": "Arrow International sent an Urgent Medical Device Recall Notification letter dated June 1, 2017, and Recall Acknowledgement Form to their domestic consignees via FedEx 2-day. Customers were advised to immediately inspect stock, discontinue use and quarantine any products with the product codes and lot numbers listed, so that the affected products can be returned to Arrow. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow the firm to document the amount of product you have on hand for return. A customer service representative will the customer with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Arrow International. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow the company to document your receipt of the letter. Customers that have any questions can contact their local sales representative or Customer Service at 1-866-246-6990.", "distribution_pattern": "Nationwide Distribution to AZ, CA, MA, MO, NC, NY, OR & SD", "openfda": { "k_number": [ "K161125", "K073473", "K241540", "K173618", "K212959", "K140318", "K213593", "K091352", "K242893", "K113008", "K172258", "K071234", "K233948", "K200812", "K051679", "K160514", "K251103", "K033650", "K251231", "K041727", "K050995", "K240050", "K051337", "K041134", "K141618", "K123813", "K250913", "K173063", "K081625", "K193183", "K143701", "K101138", "K103255", "K191175", "K160583", "K123621", "K153094", "K252945", "K200195", "K170263", "K042593", "K132133", "K092064", "K152829", "K120697", "K111043", "K030524", "K173820", "K222568", "K261849", "K223766", "K203726", "K092596", "K133853", "K112050", "K153617", "K250955", "K081626", "K253399", "K251211", "K163478", "K200410", "K080891", "K031346", "K071660", "K150442", "K201775", "K121273", "K260816", "K071554", "K230453", "K223077", "K233270", "K070242", "K122878", "K081808", "K173284", "K170992", "K103260" ], "registration_number": [ "3003898360", "2030404", "3012198618", "9617277", "3005334138", "3009077524", "3005012805", "3032807464", "3033527241", "1000601180", "2518586", "3016076141", "3010952312", "2032112", "3005467144", "3013403214", "3009490946", "2030624", "3008496839", "3009196578", "3008516548", "2182269", "3011763071", "3007695959", "3011610434", "3023245", "3003493679", "1928237", "3017894900", "2134243", "3038966633", "3013844297", "1225687", "3013162291", "3035950510", "2024311", "2011171", "2124215", "1061124", "3014745562", "2032350", "1721686", "3013300026", "3009537152", "3007738736", "3019807891", "8043817", "3000126629", "3015276088", "1058584", "3008363989", "9610482", "2134265", "3017060084", "3012179728", "3031397684", "3002619337", "3010398867", "9681834", "3013944123", "3008497357", "3010432890", "3010273872", "3012127758", "3017461134", "3016171942", "3010041511", "3019216", "3033508292", "2090040", "3003594449", "2029275", "3009888344", "9612283", "3015859709", "9673241", "3005403518", "3014272734", "3005877899", "3011137372", "3033527283", "2939520", "9710602", "3008452825", "3016678045", "3012833053", "8010026", "3013734919", "2531814", "9680794", "3038718997", "3032109181", "3009350690", "3006985147", "9680579", "3015551113", "3011416394" ], "fei_number": [ "3003898360", "1000219637", "3012198618", "3003076831", "3005334138", "3009077524", "3005012805", "3032807464", "3002808327", "3033527241", "1000601180", "2518586", "3016076141", "3010952312", "3005467144", "3013403214", "3009490946", "1000306431", "3008496839", "3009196578", "3008516548", "2182269", "3011763071", "3007695959", "3011610434", "3005747797", "3023245", "3002615969", "3003493679", "1928237", "3017894900", "3038966633", "3002626007", "3013844297", "3013162291", "3035950510", "3002095335", "2024311", "2011171", "2124215", "3014745562", "1721686", "3003513129", "3013300026", "3003309342", "3009537152", "3007738736", "3019807891", "3000126629", "3015276088", "3008363989", "3001451463", "3003094575", "3017060084", "3012179728", "3031397684", "3002619337", "3010398867", "3013944123", "3008497357", "3010432890", "3010273872", "3012127758", "3017461134", "3016171942", "3010041511", "3019216", "1000512168", "3033508292", "3003594449", "1000519796", "3002808457", "3009888344", "3001726808", "3015859709", "3002808529", "3005403518", "3014272734", "3005877899", "3003248396", "3033527283", "3003190524", "2939520", "1000203464", "3008452825", "3016678045", "3012833053", "3003737899", "3013734919", "2828", "3038718997", "3032109181", "3009350690", "3006985147", "3015551113", "3011416394", "3000206435" ], "device_name": "Catheter, Ultrasound, Intravascular", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1200", "device_class": "2" } } ] }