PCEA ASV Yellow Microbore — Class II medical device recall Z-0386-2019
Terminated recall by Becton Dickinson & Company, reported 2018-11-14, distributed nationwide. The products have the potential to leak between the connection of the male luer lock and the yellow striped tu
| Recall number | Z-0386-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Company, Franklin Lakes, NJ, United States |
| Recall initiated | 2018-09-26 |
| Classified | 2018-11-03 |
| Reported by FDA | 2018-11-14 |
| Terminated | 2020-04-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, SA |
| Quantity | 566,737 total |
| Reason classes | packaging |
| Lot numbers | 13115436, 13115751, 13116634, 13125080, 14015841, 14016290, 14016373, 14025707, 14026388, 14026691, 14035268, 14035806, 14036236, 14036825, 14045325, 14056317, 14066080, 14066846, 14075202, 14076307, 14077092, 14085232, 14085752, 14086964, 14095389, 14096388, 14096716, 14105065, 14106255, 14106583, 14115971, 14116627, 14116628, 14125371, 15015678, 15016044, 15016971, 15025581, 15026194, 15026195 and 83 more |
| Model numbers | 30893, 30893-07 |
Product
PCEA ASV Yellow Microbore, Catalog Numbers 30893, 30893-07 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Identification Stripe. Anti-siphon valve. Set cannot be used for gravity infusion 1. Connect PCA syringe to female luer on administration set. 2. Push on syringe plunger to prime set. 3. Refer to PCA module directions for Use for complete loading and operating instructions. Notes: The set should be changed according to the facility protocol or in accordance with currently recognized guidelines for IV therapy. Antisiphon sets cannot be primed by gravity.
Reason for recall
The products have the potential to leak between the connection of the male luer lock and the yellow striped tubing.
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-0386-2019. 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.