CMS-8934 Custom Phlebectomy Tray Recalled Due to Sterility Assurance Concerns
Custom Medical Specialties is recalling 20 sterile phlebectomy trays because they contain sodium chloride bags subject to a separate recall for leaking.
The agency’s classification
FDA (Drugs): 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk scenarios.
Plain-English summary
Custom Medical Specialties, Inc. is recalling 20 units of the CMS-8934 Custom Phlebectomy Tray, Sterile. The recall is due to a lack of assurance of sterility. The trays contain Hospira 0.9% Sodium Chloride bags that were previously subject to a recall for leaking bags.
The affected product is identified by Lot # 25915-1111 with an expiration date of 12/2012. The product was distributed in Georgia, Maryland, and Massachusetts. The trays also contain other components not listed in the product description.
Consumers and healthcare facilities should stop using the affected trays and contact the manufacturer for further instructions or a return.
The recalled product
- Product
- CMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium chloride 0.9% 50 mL, Manufactured by: CMS, Custom Medical Specialties, Inc., 330 East Main St, PO Box 177, Pine level, NC 27568, the tray also contains other components not listed in this product description.
- Manufacturer
- Custom Medical Specialties, Inc.
- Category
- Medical Device — Surgical Trays
- Hazard
- Affected units
- 20
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 #: 25915-1111
- Exp 12/2012
Distribution
Part of a larger recall action
This product is one of 3 recalled by Custom Medical Specialties, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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