{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "181457", "product_res_number": "Z-2288-2020", "event_date_initiated": "2020-05-08", "event_date_created": "2020-06-05", "recall_status": "Open, Classified", "res_event_number": "85645", "product_code": "BSO", "k_numbers": [ "K140110" ], "product_description": "Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes (US)\nOT19TAGSK\nOT19TAGSKA\nOT19TAPSK\nOT19TCGLK\n\nProduct Codes (OUS)\nAT-05501-NRF\nOT19HBPSS\nUM-05400-NRF\nASK-05500-NRON\nEJ-05400-NRON\nOU-05500-NRON\nTU-05500-NRON\n\nThe Arrow Epidural Catheter kit permits access to the epidural space for administration of epidural anesthetic. The epidural catheter kit is intended for use up to 72 hours.", "code_info": "Lots:  (Dist'd in US) 23F19A0260 23F19M0224 23F19E0120 23F19L0014 23F19B0184  (Dist'd OUS) 71F19M0710 71F18K1579 71F18F1429 71F18J2111 71F20A1078 71F20A1614 71F19E2019 71F19L0269 71F19L2068 71F19K1049 71F19K2042 71F19L0977 71F19M1319 71F20A0805 71F20A0812 71F20A0813 71F19J0604 71F19K1653 71F19K2501 71F19M0326 71F20A1819 71F20A2040 71F20A0044 71F19K2043 71F19L0359", "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\n866-396-2111", "reason_for_recall": "Nine complaints reported that the rotatable collar on the filter had detached, causing a leak.", "root_cause_description": "Under Investigation by firm", "action": "On May 8, 2020, the firm distributed \"Urgent Medical Device Recall\" letters to affected customers. The letter informed customers that the product was being recalled due to complaints reporting that the rotatable collar on the filter had detached, causing a leak. If a leak presents during use, an alternative filter may be required, or the catheter may need to be removed and replaced with a new kit.\n\nCustomers are asked to take the following actions:\n\n1. If you have affected stock, immediately identify product, discontinue use and quarantine any products with the product codes and lot numbers listed above.\n\n2. To acknowledge receipt of the Urgent Medical Device Recall Notice or to return product, complete the included 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\nhand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical.\n\n3. 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 firm to document your receipt of this letter.\n\nIf you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.", "product_quantity": "109 eaches (US), 23,021 (OUS)", "distribution_pattern": "US Domestic distribution to CA, FL, and MT. International distribution to AT, AU, DE, ES, FR, JP and SG.", "openfda": { "k_number": [ "K111031", "K090884", "K171193", "K971851", "K133316", "K981329", "K823702", "K832352", "K802065", "K152952", "K951927", "K062005", "K930539", "K150731", "K080675", "K102594", "K110814", "K043456", "K173541", "K050557", "K840202", "K102460", "K022019", "K200624", "K191470", "K850009", "K171584", "K895204", "K143164", "K935927", "K051401", "K150789", "K922113", "K051524", "K193664", "K850439", "K181782", "K023233", "K884969", "K897194", "K000886", "K991879", "K832232", "K081404", "K032390", "K042488", "K072702", "K954584", "K991259", "K850505", "K951092", "K992471", "K822436", "K924995", "K001717", "K023140", "K153297", "K162522", "K901129", "K854601", "K930219", "K230603", "K896712", "K063234", "K241410", "K172777", "K070465", "K122661", "K093920", "K161232", "K993592", "K072050", "K863792", "K140110", "K231242" ], "registration_number": [ "2030624", "3011270181", "3011137372", "3009746061", "1423507", "1643817", "3006946348", "3010170586", "1043214", "3044854930", "1061124", "2020735", "3010321647", "3009888344", "9680794", "3015460875", "3015443199", "3003767927", "3021006165", "1417592", "1644312", "2134812", "1316297", "3013162291", "2243072", "1319639", "3015972753", "3006425876", "1643059", "3009039068", "3004784537", "3004893332", "3009599228", "2523676", "2025816", "1018470", "2029275", "3016678045", "9680425", "3007441619", "3003915875", "9617604", "1000563940", "3006188722", "2521402", "3010041511", "3004365956", "9611612", "9610825", "3002806603", "3003898360", "3013764800", "3015859709", "3014656749", "2618282" ], "fei_number": [ "1000306431", "3000206435", "3011270181", "3009746061", "3014656749", "1643817", "3006946348", "3010170586", "3005747797", "1043214", "3044854930", "3008002452", "2020735", "3010321647", "3009888344", "3015460875", "3015443199", "3003767927", "3021006165", "1417592", "1316297", "1000117748", "3013162291", "2243072", "3015972753", "3006425876", "1643059", "3009039068", "3004784537", "3004893332", "3002806469", "3009599228", "2523676", "2025816", "1018470", "1000138054", "3016678045", "3003737899", "3007441619", "3002558692", "2649711", "3003915875", "1000563940", "3007596547", "3006188722", "2521402", "3010041511", "3004365956", "3002806603", "3003898360", "1000512168", "3002807847", "3013764800", "3015859709", "3002827704" ], "device_name": "Catheter, Conduction, Anesthetic", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5120", "device_class": "2" } } ] }