Pressure Injectable Multi- Lumen Central Venous Pressure Injectable… — Class II medical device recall Z-0996-2018
Terminated recall by Arrow International Inc, reported 2018-03-21, distributed in FL, KY, MI, NJ, OH, SC, TX. Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration da
| Recall number | Z-0996-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2017-11-27 |
| Classified | 2018-03-13 |
| Reported by FDA | 2018-03-21 |
| Terminated | 2020-09-22 |
| Distributed | FL, KY, MI, NJ, OH, SC, TX |
| Quantity | 23,904 in |
Product
Pressure Injectable Multi- Lumen Central Venous Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.
Reason for recall
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
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-0996-2018. 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.