Trocar KIT recall: Sterility Concern
TROCAR KIT, STERILE DISPOSABLE** DEVICE 1 KIT 1 PELLET 2 KIT 3 KIT 4 KIT 5 KITS 6 KIT (7 DIFFERENT PRODUCTS)
Why was Trocar KIT recalled?
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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?
Rx #'s: T0372867 T0387431 T0388104 T0389467 T0389651 T0389841 T0391671 T0394240 T0395182 T0395583 T0396607 T0397069 T0397176 T0398192 T0399822 T0399900 T0400079 T0400081 T0400293 T0400444 T0400658 T0400794 T0400806 T0400871 T0401635 T0401644 T0401957 T0402166 T0402388 T0402390 T0402553 T0402656 T0402943 T0403559 T0405372 T0405460 T0406116 T0406555 T0406565 T0406984 T0407064 T0407383 T0407394 T0407440 T0407793 T0408122 T0408306 T0408399 T0408744 T0409050 T0409093 T0409107 T0409169 T0409178 T0396714 T0394672 T0395926 T0394672 T0394672 T0398564 T0394672
- Product
- TROCAR KIT, STERILE DISPOSABLE** DEVICE 1 KIT 1 PELLET 2 KIT 3 KIT 4 KIT 5 KITS 6 KIT (7 DIFFERENT PRODUCTS)
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Quantity
- 64 units
- Distribution
- Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
- Recall date
- August 22, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)