HemosIL RecombiPlasTin recall
HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic coagulation pathway and the…
Why was HemosIL RecombiPlasTin recalled?
Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G), Part No. 0020009580 (8 mL Size) due to being Out of Specification.
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?
Part Number applies to all: 0020002950 - all product lots. Lot Numbers: 1) N0716706 Exp. Date 5/31/2013, 2) N0817321 Exp. Date 5/31/2013, 3) E0917396 Exp. Date 9/30/2013, 4)) N0917378 Exp. Date 9/30/2013, 5) N1118029 Exp. Date 10/31/2013, 6) N0128669 Exp. Date 1/31/2014, 7) N0329291 Exp. Date 2/28/2014, 8) N0429596 Exp. Date 3/31/2014, 9) N0520056 Exp. Date 5/31/2014,10) E0720822 Exp. Date 7/31/2014, 11) N0821174 Exp. Date 8/31/2014, 12) N091388 Exp. Date 9/30/2014, 13) N0921522 Exp. Date 9/30/2014, 14) N0132676 Exp. Date 1/31/2015 and 15) N1222567 Exp. Date 1/31/2015.
- Product
- HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic coagulation pathway and the…
- Recalling firm
- Instrumentation Laboratory Co.
- Quantity
- Kits per product:1)11080, 2)11603, 3)11487, 4)11483, 5)11290, 6)11562, 7)11535, 8)11577, 9)11505, 10)11708,11)11579,12)11580, 13&14) not distributed
- Distribution
- Worldwide Distribution- US (nationwide) including states of: MA, ME, CT, NJ, NY, PA, MD, VA, NC, SC, GA, FL, AL, TN, MS, KY, OH, IN, MI, IA, WI, MN, SD, MT, IL, MO, KS, NE, LA, AR, OK, TX, CO, ID, AZ, CA, OR, WA, AK, RI, VT and the countries of: Angola, Argentina, Australia, Austria, Belgium, Bermuda, Brazil, Bulgaria, Canada, Caribbean, Chile, Colombia, Costa Rica, Czech, Denmark, Dubai, Ecuador, Egypt, France, Germany, Gibraltar, Great Britain, Greece, Guatemala, Hungary, India, Indonesia, Iran, Israel, Italy, Jamaica, Jordan, Korea, Kosovo, Kuwait, Lebanon, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad, Turkey, Ukraine, Uruguay, Vietnam, and Japan.
- Recall date
- July 31, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)