Data Foundry

Medical device recalls 2013

HemosIL RecombiPlasTin 2G — Class II medical device recall Z-1784-2013

Terminated recall by Instrumentation Laboratory Co., reported 2013-07-31, distributed nationwide. Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G), Part No. 0020009580 (8 mL Size) due

Recall numberZ-1784-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmInstrumentation Laboratory Co., Bedford, MA, United States
Recall initiated2013-04-09
Classified2013-07-22
Reported by FDA2013-07-31
Terminated2015-05-06
DistributedNationwide (US)
Countries outside the USAR, AT, AU, BE, BG, BM, BR, CA, CH, CL, CO, CR, CZ, DE, DK, EC, EG, ES, FR, GB, GR, GT, HU, ID, IL, IN, IR, IT, JM, JO, JP, KR, KW, LB, LT, MA, MT, MX, MY, NL, NO, PA, PE, PH, PL, PT, RO, RS, RU, SA, SE, SG, SI, TH, TR, TT, TW, UA, UY, VN, ZA
Reason classesspecification failure
Model numbers0020002950
Expiration dates2013-05-31, 2013-09-30, 2013-10-31, 2014-01-31, 2014-02-28, 2014-03-31, 2014-05-31, 2014-07-31, 2014-08-31, 2014-09-30, 2015-01-31

Product

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.

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1784-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.