Safety PICC Insertion Tray Recalled for Incorrect Non-Sterile Packaging Item
Custom Healthcare Systems is recalling Safety PICC Insertion Trays because the outer packaging contains an incorrect non-sterile saline flush syringe.
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. The hazard involves a packaging error where a non-sterile item is included in the outer package, but the source explicitly states the interior sterile kit is correct and no adverse issues affect it, fitting the criteria for moderate severity.
Plain-English summary
Custom Healthcare Systems, Inc. is recalling Safety PICC Insertion Trays with Chloraprep OneStep (Model #5026CL-9). The recall involves 3 cases of Lot #92414, 25 cases of Lot #100214, and 24 cases of Lot #100914. These products were distributed to Connecticut.
The recall is due to an incorrect item number packed within the outside "piggybacked" package. The non-sterile outside package mistakenly contains Item #8881579121, a prefilled saline flush syringe. This non-sterile product cannot be dropped into the sterile field. The interior sealed sterile kit is correct, and no adverse issues affect that part of the item.
The product is packaged for physician use only. Users should stop using the affected trays and contact the manufacturer for instructions.
The recalled product
- Product
- Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.
- Manufacturer
- Custom Healthcare Systems, Inc.
- Category
- Medical Device — Surgical Kits
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 (2)
- Lot#92414 Exp Date 11/1/15
- Lot#100214 Exp Date 11/1/15 Lot#100914 Exp Date 11/1/15
Distribution
Distributed in 1 state:
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