Thermo Fisher Recalls Cardinal Health Specimen Containers Due to Plastic Shavings
Thermo Fisher Scientific is recalling Cardinal Health 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential foreign material (plastic shavings) in a sterile medical device, which poses a risk of harm even without reported injuries.
Plain-English summary
Thermo Fisher Scientific is recalling Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen containers with orange caps (Catalog number: CHB13905). The recall involves 514,200 units distributed in Ohio.
The recall was initiated because the containers may potentially contain plastic shavings on the threaded surfaces between the closure and the vial. The affected lots are 1237250, 1238659, 1239271, 1240169, 1241734, 1246082, 1248994, 1250049, 1250718, 1251449, and 1252504.
The FDA has classified this as a Class II recall. Users should check their inventory for the specific catalog number and lot numbers listed above.
The recalled product
- Product
- Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen container with orange cap (100/pk) Catalog number: CHB13905
- Manufacturer
- Thermo Fisher Scientific (Monterrey)
- Affected units
- 514,200
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 (11)
- Lot # 1237250
- 1238659
- 1239271
- 1240169
- 1241734
- 1246082
- 1248994
- 1250049
- 1250718
- 1251449
- 1252504
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)
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FDA (Devices) · 2020-06-03
- ModerateThermo Fisher Recalls Cardinal Health Sterile Specimen Containers
FDA (Devices) · 2019-11-13
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