FDA recall Z-3404-2018

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, 5

Reason for recall

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.

Distribution

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

Key facts

Status

Terminated

Initiation date

2018-07-20

Report date

2018-10-10

Termination date

2020-05-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Allentown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3404-2018