RecallRadar

FDA Device recall Z-2771-2016

Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days

On 2016-09-21 the FDA classified a Class II recall of Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days by Arrow International, citing notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2771-2016
ClassificationClass II
Statusterminated
Initiated2016-02-17
Published2016-09-21
Last updated2026-09-13 11:54 UTC
CompanyArrow International
DistributionFL, MD, NC, OH

Product

Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components

Reason

Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.

Identifiers

code_info
Lot/Batch Numbers: 23F15L0662,23F15J0260,23F15K0983,23F15G0159,23F15J1102,23F15J0259 23F15C1225,23S15G0973,23F15H103…Lot/Batch Numbers: 23F15L0662,23F15J0260,23F15K0983,23F15G0159,23F15J1102,23F15J0259 23F15C1225,23S15G0973,23F15H1033,23F15F0358,23F15K0345,23F15D1514 23F15C1226,23F15H0919,23F15E1091,23F15H0014,23F15D0241,23F15J0533 23F15E1094,23F15H0020,23F15H0740,23F15K1009,23F15J0431,23F15F1836 23F15H0857,23F15K0012,23F15M0313,23F15G0871,23F15J0285

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2771-2016%22

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