CLASS II Device recall · Reported 29 May 2019 · FDA Enforcement Report
Thio Med w/Dex, Hem, Vit K recalled by Remel
Remel is recalling Thio Med w/Dex, Hem, Vit K, distributed nationwide in the US. The recall was initiated on 17 Apr 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1406-2019
- FDA event ID
- 82683
- Recalling firm
- Remel, Lenexa, KS
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Apr 2019
- FDA classified
- 22 May 2019
- Reported
- 29 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 17 Apr 2019 | Recall initiated by company | |
| 22 May 2019 | Classified by FDA | +35 days |
| 29 May 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Thio Med w/Dex, Hem, Vit K (10ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
Where it was distributed
Worldwide Distribution -US Nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico. International distribution to Canada.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaryland
Questions about this recall
Is Thio Med w/Dex, Hem, Vit K recalled?
Yes. Remel recalled Thio Med w/Dex, Hem, Vit K on 17 Apr 2019. The recall is Class II and its status is Terminated. Recall number Z-1406-2019.
Why was it recalled?
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.
Which lots are affected?
Material Number: R07182; Lot Number (Labeled Expiration Date): 309155 (12/12/2018), 329971 (01/17/2019), 346674 (02/26/2019), 354842 (03/07/2019), 376323 (04/18/2019), 398234 (06/06/2019), 404772 (06/13/2019).
Where was it sold?
Worldwide Distribution -US Nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico. International distribution to Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Remel
All 86| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | GC Agar Base R04030 recalled by Remel | Remel | Other | Nationwide |
| Device | CLASS II | Yeastone Broth, 10/BOX YY3462 recalled by Remel | Remel | Mold | Nationwide |
| Device | CLASS II | Campy CVA Medium, R01272 recalled by Remel | Remel | Other | Nationwide |
| Device | CLASS II | Camhb W/lhb, Manual, 10/box Ycp112-10 Brucella Broth, 10/box Yt3450 recalled | Remel | Other | Nationwide |
| Device | CLASS II | Blood/EMB, Levine, Product Number R02041 recalled by Remel | Remel | Listeria | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |