Z-2288-2020Class II

Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes (US) OT19TAGSK...

Name: Z-2288-2020 Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes (US) OT19TAGSK...
Creator: Arrow International Inc
Published: 2020-05-08
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2020-05-08 / Open, Classified

FDA source

Arrow International Inc began a recall of Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes (US) OT19TAGSK OT19TAGSKA OT19TAPSK OT19TCGLK Product Codes (OUS)... on 2020-05-08. FDA classified it as Class II and gives the reason as "Nine complaints reported that the rotatable collar on the filter had detached, causing a leak". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2288-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-05-08
Posted: 2020-06-05
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes (US) OT19TAGSK OT19TAGSKA OT19TAPSK OT19TCGLK Product Codes (OUS) AT-05501-NRF OT19HBPSS UM-05400-NRF ASK-05500-NRON EJ-05400-NRON OU-05500-NRON TU-05500-NRON The 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.
Product code: BSO Catheter, Conduction, Anesthetic
Reason for recall: Nine complaints reported that the rotatable collar on the filter had detached, causing a leak.
FDA root cause: 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. Customers are asked to take the following actions: 1. If you have affected stock, immediately identify product, discontinue use and quarantine any products with the product codes and lot numbers listed above. 2. 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 [email protected]. This will allow the firm to document the amount of product you have on hand 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. 3. 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 [email protected]. This will allow the firm to document your receipt of this letter. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.
Quantity in commerce: 109 eaches (US), 23,021 (OUS)
Distribution: US Domestic distribution to CA, FL, and MT. International distribution to AT, AU, DE, ES, FR, JP and SG.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2288-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2288-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-17	2020-06-05

Product code BSO

K140110Class IIFlextip Plus Epidural Catheter;flexblock Continous Peripheral Nerve Block Catheter Kit/setTeleflex, Inc. / cleared 2015-03-27

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)