Thermo Fisher Recalls Cardinal Health Sterile Specimen Containers
Thermo Fisher Scientific is recalling Cardinal Health sterile specimen containers that may contain plastic shavings on threaded surfaces.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential foreign material (plastic shavings) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Thermo Fisher Scientific is recalling Cardinal Health Brand 120mL/53mm sterile specimen containers with orange caps. The recall involves 2,979,600 units distributed in Ohio.
The containers are being recalled because they may potentially contain plastic shavings on the threaded surfaces between the closure and the vial. Specific lot numbers are listed in the official recall notice.
Healthcare facilities and consumers who have these specific containers should stop using them and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Cardinal Health Brand 120mL/53mm sterile specimen container with orange cap, 75 pieces/pack, 4 packs/case Catalog number: CHB13904
- Manufacturer
- Thermo Fisher Scientific (Monterrey)
- Hazard
- Affected units
- 2,979,600
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot # 1236428
- 1237502
- 1237804
- 1238412
- 1238880
- 1239711
- 1241129
- 1242233
- 1243303
- 1243863
- 1246080
- 1246545
- 1247463
- 1248348
- 1248489
- 1249612
- 1250496
- 1250723
- 1251447
- 1251519
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Thermo Fisher Scientific (Monterrey) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Thermo Fisher Scientific (Monterrey)
See all →- HighThermo Fisher Recalls Non-Sterile Bio-Tite Specimen Containers
FDA (Devices) · 2020-06-03
- HighThermo Fisher Recalls Cardinal Health Specimen Containers Due to Plastic Shavings
FDA (Devices) · 2019-11-13
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