FDA Device recall Z-1784-2013
HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size)
- FDA Device
- Class II
- terminated
- Published 2013-07-31
On 2013-07-31 the FDA classified a Class II recall of HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size) by Instrumentation Laboratory, citing instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G), Part No. 0020009580 (8 mL Size) due to being Out of Specification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1784-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-09 |
| Published | 2013-07-31 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Instrumentation Laboratory |
| Distribution | US |
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
Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G), Part No. 0020009580 (8 mL Size) due to being Out of Specification.
Identifiers
| code_info | Part Number applies to all: 0020002950 - all product lots. Lot Numbers: 1) N0716706 Exp. Date 5/31/2013, 2) N081732…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1784-2013%22
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