FDA Device recall Z-3404-2018
DESIGN OPTIONS¿ PAIN MANAGEMENT TRAY, Material Numbers 530029, 530029, 530031, 530035, 530041, 530048, 530068, 530071, 530083, 530108, 5301…
- FDA Device
- Class II
- terminated
- Published 2018-10-10
On 2018-10-10 the FDA classified a Class II recall of DESIGN OPTIONS¿ PAIN MANAGEMENT TRAY, Material Numbers 530029, 530029, 530031, 530035, 530041, 530048, 530068, 530071, 530083, 530108, 5301… by B Braun Medical, citing the catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3404-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-20 |
| Published | 2018-10-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | B Braun Medical |
| Distribution | US |
Product
DESIGN OPTIONS¿ PAIN MANAGEMENT TRAY, Material Numbers 530029, 530029, 530031, 530035, 530041, 530048, 530068, 530071, 530083, 530108, 530112, 530122, 530123, 530124, 530132, 530133, 530134, 530138, 530141, 530142, 530149, 530153, 530155, 530159, 530160, 530164, 530168, 530169, 530171, 530175, 530177, 530179, 530180, 551028, 551266, 551342, 551344, 551394, 551411, 551437, 551474, 551554, 551572, 551624, 551630, 551671, 551672, 551714, 551731, 551732, 551749, 551769, 551771, 551773, 551791, 551810, 551816, 551849, 551859, 551875, 551879, 551889, 551920, 551922, 551938, 551942, 551951, 551971, 551994, 551997, 551998, 552006, 552011, 552020, 552021, 552030, 552031, 552038, 552041, 552047, 552048, 552051, 552076, 552077, 552079, 552083, 552089, 552099, 552100, 552101, 552112, 552113, 552116, 552117, 552119, 552121, 552122, 552123, 552125, 552126, 552133, 552135, 552136, 552147, 552149, 555030, 555040, 555051, 555061, 555063, 555067, 555070, 555076, 555079, 555083, 555091, 555098, 555100, 555110, 555170, 555172, 555175, 555202, 555204, 555215, 555217, 555259, 555271, 555277, 555290, 555296, 555299, 555325, 555340, 555357, 555374, 555421, 555422, 555438, 555449, 555450, 555482, 555483, 555484, 555498, 555525, 555551, 555569, 555578, 555579, 555601, 555647, 555660, 555704, 555706, 555757, 555779, 555854, 555857, 555884, 555904, 555931, 555951, 555987, 570180, 570205, 570222, 570234, 570245, 570246, 570269, 570285 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.
Reason
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Identifiers
| code_info | Batch: 61591833, 61599662, 61602691, 61607729, 61616956, 61585954, |
|---|
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-3404-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.