FDA Device recall Z-1407-2019
Thio Med w/Dex, Hem, Vit K(10ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cul…
- FDA Device
- Class II
- terminated
- Published 2019-05-29
On 2019-05-29 the FDA classified a Class II recall of Thio Med w/Dex, Hem, Vit K(10ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cul… by Remel, citing potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1407-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-04-17 |
| Published | 2019-05-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Remel |
| Distribution | US |
Product
Thio Med w/Dex, Hem, Vit K(10ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
Reason
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
Identifiers
| code_info | Material Number: R07180; Lot Number (Labeled Expiration Date): 314206 (12/20/2018), 315673 (12/25/2018), 322659 (01/07/…Material Number: R07180; Lot Number (Labeled Expiration Date): 314206 (12/20/2018), 315673 (12/25/2018), 322659 (01/07/2019), 330648 (01/21/2019), 333828 (01/24/2019), 337102 (01/31/2019), 343936 (02/14/2019), 347392 (02/28/2019), 353577 (03/06/2019), 366056 (03/28/2019), 367423 (04/02/2019), 370220 (04/09/2019), 377044 (04/22/2019), 380480 (04/29/2019), 390571 (05/16/2019), 391563 (05/20/2019), 407306 (06/20/2019), 418374 (07/18/2019). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1407-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.