Phoenix AP AST Indicator Bag — Class II medical device recall Z-0935-2019
Terminated recall by Becton Dickinson & Co., reported 2019-03-06, distributed in AL, AR, AZ, CA, CO, CT, DC, FL…. Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of te
| Recall number | Z-0935-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2018-12-20 |
| Classified | 2019-02-23 |
| Reported by FDA | 2019-03-06 |
| Terminated | 2020-04-10 |
| Distributed | AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, WY |
| Countries outside the US | AR, AU, BD, BE, BR, CA, CL, CN, CR, DO, EC, GT, ID, IN, JP, KR, KY, LK, MX, MY, NZ, PA, PE, PH, PK, SG, TH, TW, UY, VN |
| Quantity | 62,880 total |
| Lot numbers | 8150669, 8150670, 8159691, 8170557, 8170562, 8190530, 8190531, 8206585, 8208579, 8208581, 8213633, 8213635, 8213696, 8218605, 8218607, 8225578, 8225579, 8234505, 8234533, 8234684 |
| Model numbers | 246006 |
Product
Phoenix AP AST Indicator Bag, Catalog Number 246006
Reason for recall
Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.
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-0935-2019. 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.