Data Foundry

Medical device recalls 2019

Arrow CVC 2 Lumen — Class II medical device recall Z-0723-2019

Terminated recall by Arrow International Inc, reported 2019-01-23, distributed nationwide. The lidstock states the incorrect priming volume and flow rates.

Recall numberZ-0723-2019
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmArrow International Inc, Reading, PA, United States
Recall initiated2018-11-14
Classified2019-01-11
Reported by FDA2019-01-23
Terminated2020-06-04
DistributedNationwide (US)
Countries outside the USAR, CA, CL, CR, DO, EC, PE
Quantity15 in
Lot numbers14F18E0121, 14F18F0336

Product

Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402 The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access, including, but not limited to the following: " Lack of usable peripheral IV sites " Central venous pressure monitoring " Total parenteral nutrition (TPN) " Infusions of fluids, medications, or chemotherapy " Frequent blood sampling or receiving blood transfusions/blood products

Reason for recall

The lidstock states the incorrect priming volume and flow rates.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0723-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.