Baxter Non-DEHP Micro-Volume Extension Set — Class II medical device recall Z-2687-2016
Terminated recall by Baxter Healthcare Corp., reported 2016-09-07, distributed in FL, GA, IL, KS, KY, MI, MO, NC…. Some of the individual extension set packages were improperly sealed, compromising the sterility of the produc
| Recall number | Z-2687-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Round Lake, IL, United States |
| Recall initiated | 2012-12-14 |
| Classified | 2016-08-29 |
| Reported by FDA | 2016-09-07 |
| Terminated | 2016-12-23 |
| Distributed | FL, GA, IL, KS, KY, MI, MO, NC, ND, OH, PA, PR, SC, TN, TX, WV |
| Countries outside the US | CA |
| Quantity | 15,257 units |
| Reason classes | sterility |
| Lot numbers | UR12E03108 |
Product
Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm), Volume 0.32 mL; an Rx sterile, single use nonpyrogenic fluid pathway; 50 sets per case; For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
Reason for recall
Some of the individual extension set packages were improperly sealed, compromising the sterility of the product.
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-2687-2016. 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.