FDA Device Recall Z-0004-2024: ARROW INTERNATIONAL Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0004-2024.

Recall Res Number

Z-0004-2024

Recalling Firm / Manufacturer

ARROW INTERNATIONAL Inc.

FEI Number

3013162291

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2023-08-10

Date Posted

2023-10-05

Date Terminated

N/A

Product Code

LJS

Event Number

93014

Product Quantity

172 units

Product Description Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter, intravascular, therapeutic, long-term greater than 30 days

Reason for Recall This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.

Action Details Teleflex/Arrow International issue an URGENT MEDICAL DEVICE RECALL notice on 08/10/2023 by FedEx 2nd day mail. The letter explained the problem, risk to patient, and requested the following actions: Medical facilities: Immediately cease use and distribution of affected product and quarantine for return. Distributors: Immediately cease use and distribution of affected product and quarantine for return. Provide a copy of this recall notice to all customers who have received impacted product. Request they complete the Acknowledgement Form and return it to you. Firm is requesting return of the affected product.

Distribution Pattern US

Code Information / Serial Numbers Batch/Lot number 13F22G0508

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Medical Device Recall: Z-0004-2024

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer