ProTime Microcoagulation System recall
ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the foil-pouched cuvettes refrigerated 2-8C (36 - 36F); MATERIALS…
Why was ProTime Microcoagulation System recalled?
The products may have been stored at temperatures outside their required storage conditions.
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?
*** 1) Product Number: PRO3-25; Lots: All Lots; Independence Medical Catalog Number: 55L2101002; *** 2) Product Number: PRO5-25; Lots: All Lots; Independence Medical Catalog Number: ICPRO525
- Product
- ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the foil-pouched cuvettes refrigerated 2-8C (36 - 36F); MATERIALS…
- Recalling firm
- Assuramed
- Quantity
- 1) 72 units; 2) 56 units
- Distribution
- Nationwide Distribution including AR, AZ, CA, CO, FL, IL, KY, LA, MI, NJ, NY, OH,OK, OR, SC, TX, UT, and WA.
- Recall date
- September 25, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)