Chemotherapy gowns recalled over an expiration date printed two years late
Cardinal Health is recalling 251,165 ChemoPlus gowns and sleeves because the packaging shows a five-year shelf life when the product's actual shelf life is three years.
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: Scored 2 under the minor labeling criterion: the record cites an incorrect printed expiration date with no stated product defect or reported harm.
Plain-English summary
ChemoPlus gowns and sleeves from Cardinal Health 200, LLC are being recalled. Affected items include the ChemoPlus Full Coverage Sleeve, universal (CT5500T), and ChemoPlus Full Coverage Gowns in closed-back regular/medium, large, extra large and extra extra large (CT5502T, CT5503T, CT5504T, CT5505T) and open-back large and extra large (DP5001GT, DP5002GT) among other product codes, all medium blue and non-sterile.
The affected gowns have the incorrect expiration date on the product packaging. The product has a shelf life of three years, which is mislabeled on the packaging as five years.
The recall covers 251,165 units. Each product code is affected up to a stated lot number, listed in the enforcement record. Distribution was worldwide, including nationwide in the United States and to Canada. The FDA has classified the action as Class II.
A date printed later than the true shelf life could allow a gown to be kept in service past its validated life. The enforcement record reports no injuries. Facilities should follow Cardinal Health's instructions.
The recalled product
- Product
- ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile; CT5502T ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Blue, Non-sterile; CT5503T ChemoPlus Full Coverage Gown, Closed Back…
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 251,165
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 (10)
- CT5500TS 21KAS095 CS- 50885380172388 EA-20885380172387
- CT5502TS 21KAS059 CS- 50885380172401 EA-10885380172403
- CT5503TS 21KAS106
- 21LAS004
- 21LAS017 CS- 50885380172425 EA-10885380172427
- CT5504TS 21KAS064
- 21KAS072
- 21KAS109 CS- 50885380172449 EA-10885380172441
- CT5505TS 21KAS019
- 21KAS031 CS- 50885380172463 EA-10885380172465
Distribution
Distributed nationwide across the United States.
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