Reported Sep 24, 2014 · Terminated
Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile. These catheters are indicated for the…
Teleflex Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teleflex Medical · 2917 Weck Dr · Research Triangle Park, NC · 27709-0186
Is this the product you have?
- 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.
- Lot codes and dates
14 of 14 products
Products covered by this recall Model / number Product as published 402100060Lot #13491 & 13501 402140120Lot #13371, 13391 & 13511 40114014013501, 14091, 14141, 13271, 13461, 13481, 14061, 14081 & 14101 402140160Lot #13411, 13291, 13311, 13301, 13391 & 13491 402140240Lot #13311 & 13391 403300100Lot #13311, 13411, 13461, 13481, 14041, 14091 & 14131 403340140Lot #13291 403900080Lot #13371 & 13411 403900100Lot #13261 & 13441 40214-000080Product Code #403900120, Lot #13351, 13451, 13511 & 13461 and Product Code #410200200, Lot #13411. On 1/9/2015 recall expanded to include: , Lot numbers 14101 & 13301 402140-000140Lot number: 14281 402140-0001160Lot number: 13491 402140-000180Lot number: 13391 and Product Code — 402140-000240, Lot numbers: 13391 & 14027. - Amount recalled
- 193,363 ea. + 1,140 units (total 194,503 units)
Where it was sold
- Nationwide
Why it was recalled
Misbranding: Although the product labeling identifies the catheters as "soft rubber," the Natural Rubber Latex caution statement was not printed on the product label.
This product could cause temporary or reversible health problems — stop using it.
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