(1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit… — Class II medical device recall Z-1324-2018
Terminated recall by Arrow International Inc, reported 2018-04-18, distributed in DC. Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot b
| Recall number | Z-1324-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2017-12-22 |
| Classified | 2018-04-10 |
| Reported by FDA | 2018-04-18 |
| Terminated | 2020-05-27 |
| Distributed | DC |
| Countries outside the US | BS, CA, MX, PA, SG |
| Reason classes | sterility |
| Lot numbers | 13F16L0179, 13F16L0254, 13F17B0139, 13F17B0140, 13F17B0141, 13F17B0142, 13F17B0196, 13F17C0046, 13F17C0339, 13F17D0131, 13F17D0141, 13F17D0212, 13F17E0042, 13F17E0230, 13F17E0231, 13F17E0411, 13F17E0509, 13F17E0510, 13F17E0656, 13F17E0718, 13F17E0770, 13F17E0836, 13F17E0867, 13F17F0188, 13F17F0438, 13F17F0439, 13F17F0459 |
Product
(1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21142-RH; (2) Arrowg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7 - 7.5 Fr. Catheters, Product Number: ASK-21242-MMC1; (3) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21242-UCD; (4) ARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit, Product Number: CDC-21242-1A; (5) ARROWg+ard Blue¿ PSI Kit, Product Number: CDC-29803-1A; (6) ARROWg+ard Blue¿ PSI Kit, Product Number: CDC-29903-1A
Reason for recall
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
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-1324-2018. 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.