Recall Z-1172-2020— Arrow International Inc

Name: FDA recall Z-1172-2020
Creator: U.S. Food and Drug Administration
Published: 2020-01-15

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2020-01-15, terminated 2023-03-17. It names one FDA 510(k) clearance: K140110. Product: FlexTip Plus Epidural Catheterization Kit, Product Code AK-05501. Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2020-01-15
Terminated: 2023-03-17
Firm location: Reading, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K140110 — FLEXTIP PLUS EPIDURAL CATHETER; FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SETTeleflex, Inc.·cleared 2015-03-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

FlexTip Plus Epidural Catheterization Kit, Product Code AK-05501

Reason for recall

There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.

Data sourced from openFDA. This site is unofficial and independent of the FDA.