PlainRecalls
FDA Devices Moderate Class II Terminated

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, 55181

Reported: October 10, 2018 Initiated: July 20, 2018 #Z-3404-2018

Product Description

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 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.

Details

Recalling Firm
B. Braun Medical, Inc.
Units Affected
296400
Distribution
Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.
Location
Allentown, PA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by B. Braun Medical, Inc.. Units affected: 296400.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 10, 2018. Severity: Moderate. Recall number: Z-3404-2018.

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