FDA Device recall Z-0386-2019
PCEA ASV Yellow Microbore, Catalog Numbers 30893, 30893-07 Product Usage: PCEA Administration Set
- FDA Device
- Class II
- terminated
- Published 2018-11-14
On 2018-11-14 the FDA classified a Class II recall of PCEA ASV Yellow Microbore, Catalog Numbers 30893, 30893-07 Product Usage: PCEA Administration Set by Becton Dickinson And, citing the products have the potential to leak between the connection of the male luer lock and the yellow striped tubing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0386-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-26 |
| Published | 2018-11-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Becton Dickinson And |
| Distribution | US |
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
The products have the potential to leak between the connection of the male luer lock and the yellow striped tubing.
Identifiers
| code_info | Batch numbers: 15086977 15095397 15095915 15096391 15096849 15096850 15106576 15106951 15115143 15115716 151…Batch numbers: 15086977 15095397 15095915 15096391 15096849 15096850 15106576 15106951 15115143 15115716 15115717 16017458 16025336 16025977 16036016 16045460 16045487 16055501 16065137 16065138 16065714 16066549 16067125 16067126 16067127 16067128 16077716 16085262 16085367 15026445 15026291 15026195 15026194 15025581 14116628 14115971 14106583 14106255 14105065 16085368 16087180 16095824 16095862 16096932 16096933 16105618 16107358 16107359 16115132 16125018 16126788 16127223 17015091 17016118 17016119 17017235 17025472 17026261 17026967 17036238 17036239 17056659 17057076 17057077 17065203 17065204 17065249 17066157 15016971 15016044 15015678 14125371 14116627 14056317 14045325 14036825 14036236 14035806 14096716 14096388 14095389 14086964 14085752 14085232 14077092 14076307 14075202 14066846 14066080 14035268 14026691 14026388 14025707 14016290 14016373 14015841 13125080 13116634 1311 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0386-2019%22
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