Total Hycterectomy recall: Sterility Concern
TOTAL HYCTERECTOMY (I) CANNULA 5MM XCEL SLEEVES LIF ( I ) TROCAR XCEL BLADELESS II MM (I) TROCAR 5MM BLADELESS W/STAB SLEEVE LIF ( I) NEEDLE ULTRA…
Why was Total Hycterectomy recalled?
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product code 900-2415 ,1 lots 140412654
- Product
- TOTAL HYCTERECTOMY (I) CANNULA 5MM XCEL SLEEVES LIF ( I ) TROCAR XCEL BLADELESS II MM (I) TROCAR 5MM BLADELESS W/STAB SLEEVE LIF ( I) NEEDLE ULTRA…
- Recalling firm
- Customed, Inc
- Quantity
- 1 lot ,6 units placed on hold at the firm
- Distribution
- Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
- Recall date
- September 10, 2014
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)