4043-2: 3 mL Line Draw — Class II medical device recall Z-1182-2014
Terminated recall by Smiths Medical ASD, Inc., reported 2014-03-19, distributed in AL, AZ, CA, CO, CT, DE, FL, GA…. issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
| Recall number | Z-1182-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD, Inc., Keene, NH, United States |
| Recall initiated | 2013-11-22 |
| Classified | 2014-03-12 |
| Reported by FDA | 2014-03-19 |
| Terminated | 2020-11-20 |
| Distributed | AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV |
| Countries outside the US | AT, AU, BE, BR, BZ, CA, CZ, DE, DK, ES, FI, FR, GB, GR, HU, IE, IL, IT, JP, NL, NO, PL, SE |
Product
4043-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.
Reason for recall
issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
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-1182-2014. 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.