Coloplast Titan OTR Inflatable Penile Prosthesis,18cm scrotal Bioflex cylinder set w/OTR Pump, P/N QSR9181400. Sterile EO. Manufacturer: Coloplast A/S, 3050 Denmark. Distributed by: Coloplast Corp., Minneapolis, MN 55411 USA. Indicated for male patients suffering from erectile dysfunction who are considered to be candidates for implantation of a penile prosthesis.
This recall has been terminated (originally issued November 10, 2009).
- Company
- Coloplast Manufacturing Us, Llc
- Recall Initiated
- October 6, 2009
- Posted
- November 10, 2009
- Terminated
- December 12, 2011
- Recall Number
- Z-0171-2010
- Quantity
- 3
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Coloplast determined that a portion of Titan OTR pumps were manufactured using a process that where validation activities were not completed. The Titan OTR pumps were made to our standard product specifications and have passed all in-process testing to ensure mechanical reliability of these pumps. Coloplast is not recommending product explant because there are no identified risks since the prod
Distribution
Nationwide Distribution -- FL, GA, NC.
Lot / Code Info
Lot 1919244.
Root Cause
Process control
Action Taken
Coloplast issued a customer notification letter dated October 2009 describing the affected product. For further information, contact Coloplast at 1-800-533-0464.
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