FDA Device recall Z-2661-2014

Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile

FDA Device
Class II
terminated
Published 2014-09-24

On 2014-09-24 the FDA classified a Class II recall of Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile by Teleflex Medical, citing misbranding: Although the product labeling identifies the catheters as "soft rubber," the Natural Rubber Latex caution statement was not printed on the product label.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2661-2014
Classification	Class II
Status	terminated
Initiated	2014-09-04
Published	2014-09-24
Last updated	2026-09-13 11:53 UTC
Company	Teleflex Medical
Distribution	US

Product

Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile. These catheters are indicated for the routine drainage of urine from the bladder. These catheters are not intended or designed for indwelling use.

Reason

Misbranding: Although the product labeling identifies the catheters as "soft rubber," the Natural Rubber Latex caution statement was not printed on the product label.

Identifiers

code_info	Product Code #402100060, Lot #13491 & 13501; Product Code #402140120, Lot #13371, 13391 & 13511; Product Code #40114014… Product Code #402100060, Lot #13491 & 13501; Product Code #402140120, Lot #13371, 13391 & 13511; Product Code #401140140, 13501, 14091, 14141, 13271, 13461, 13481, 14061, 14081 & 14101; Product Code #402140160, Lot #13411, 13291, 13311, 13301, 13391 & 13491; Product Code #402140240, Lot #13311 & 13391; Product Code #403300100, Lot #13311, 13411, 13461, 13481, 14041, 14091 & 14131; Product Code #403340140, Lot #13291; Product Code #403900080, Lot #13371 & 13411; Product Code #403900100, Lot #13261 & 13441; Product Code #403900120, Lot #13351, 13451, 13511 & 13461 and Product Code #410200200, Lot #13411. On 1/9/2015 recall expanded to include: Product Code: 40214-000080, Lot numbers 14101 & 13301; Product Code: 402140-000140, Lot number: 14281; Product Code: 402140-0001160, Lot number: 13491; Product Code: 402140-000180, Lot number: 13391 and Product Code; 402140-000240, Lot numbers: 13391 & 14027.

code_info

Product Code #402100060, Lot #13491 & 13501; Product Code #402140120, Lot #13371, 13391 & 13511; Product Code #40114014…

Product Code #402100060, Lot #13491 & 13501; Product Code #402140120, Lot #13371, 13391 & 13511; Product Code #401140140, 13501, 14091, 14141, 13271, 13461, 13481, 14061, 14081 & 14101; Product Code #402140160, Lot #13411, 13291, 13311, 13301, 13391 & 13491; Product Code #402140240, Lot #13311 & 13391; Product Code #403300100, Lot #13311, 13411, 13461, 13481, 14041, 14091 & 14131; Product Code #403340140, Lot #13291; Product Code #403900080, Lot #13371 & 13411; Product Code #403900100, Lot #13261 & 13441; Product Code #403900120, Lot #13351, 13451, 13511 & 13461 and Product Code #410200200, Lot #13411. On 1/9/2015 recall expanded to include: Product Code: 40214-000080, Lot numbers 14101 & 13301; Product Code: 402140-000140, Lot number: 14281; Product Code: 402140-0001160, Lot number: 13491; Product Code: 402140-000180, Lot number: 13391 and Product Code; 402140-000240, Lot numbers: 13391 & 14027.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2661-2014%22

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