Coloplast Titan OTR Inflatable Penile Prosthesis,18cm scrotal Bioflex cylinder set w/OTR Pump, P/N QSR9181400. Sterile E
FDA device recall Z-0171-2010 · posted 2009-11-10 · Terminated
Recall details
- Recalling firm
- Coloplast Manufacturing US, LLC
- 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
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FHW
- Quantity affected
- 3
- Distribution
- Nationwide Distribution -- FL, GA, NC.
- Date initiated
- 2009-10-06
- Date posted
- 2009-11-10
- Date terminated
- 2011-12-12
- Location
- Minneapolis, MN
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