Reported Jul 31, 2013 · Terminated

HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic…

Instrumentation Laboratory Co.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Instrumentation Laboratory Co. · 180 Hartwell Road · Bedford, MA · 01730-2443

Is this the product you have?

  • HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy.
Lot codes and dates

14 of 14 products

Products covered by this recall
#Product as published
1N0716706 Exp. Date 5/31/2013
2N0817321 Exp. Date 5/31/2013
3E0917396 Exp. Date 9/30/2013, 4)) N0917378 Exp. Date 9/30/2013
4N1118029 Exp. Date 10/31/2013
5N0128669 Exp. Date 1/31/2014
6N0329291 Exp. Date 2/28/2014
7N0429596 Exp. Date 3/31/2014
8N0520056 Exp. Date 5/31/2014
9E0720822 Exp. Date 7/31/2014
10N0821174 Exp. Date 8/31/2014
11N091388 Exp. Date 9/30/2014
12N0921522 Exp. Date 9/30/2014
13N0132676 Exp. Date 1/31/2015 and
14N1222567 Exp. Date 1/31/2015.
Amount recalled
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

Where it was sold

Why it was recalled

Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G), Part No. 0020009580 (8 mL Size) due to being Out of Specification.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 6, 2015 · Data as of Sep 19, 5:33 PM UTC

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