Custom Assemblies Recalls Custom Surgical Kits with Defective BD Needles
Custom Assemblies Inc is recalling 2,155 custom surgical kits because they contain BD SafetyGlide needles with loose polypropylene particulate in the fluid path.
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 involves a risk-of-harm product (foreign particulate in a medical device) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Custom Assemblies Inc is recalling 2,155 custom surgical kits manufactured for Custom Medical Specialties, Inc. The affected products include various biopsy and safety trays, such as the CMS-4153-R2 MPM Biopsy Tray and CMS-5832-R1 Custom Safety Mammo Biopsy Tray. These kits were distributed nationwide to facilities in New Jersey, Tennessee, New York, Kansas, Ohio, and California.
The recall was initiated because the kits contained BD SafetyGlide 22GA 1-inch needles that were subsequently recalled by BD. The specific defect involves loose polypropylene particulate in the fluid path, which could be expelled out of the needle during injection.
Healthcare facilities and consumers should stop using the affected kits and contact Custom Assemblies Inc for further instructions or a return. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: (a) CMS-4153-R2 MPM Biopsy TRAY (b) CMS-5832-R1 Custom Safety Mammo Biopsy Tray (c) CMS-4108 Multipurpose Safety Tray (d) CMS-3141-R6 Custom Ultrasound Tray (e) CMS-2891-R1 Custom Safety…
- Manufacturer
- Custom Assemblies Inc
- Category
- Medical Device — Surgical Kits
- Affected units
- 2,155
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 (6)
- (a) Lot Numbers: 42754-1603
- 42798-1603
- 43030-1604 (b) Lot Numbers: 42696-1602
- 43200-1604
- 433322-1605 (c) Lot Numbers: 43056-1604
- (d) Lot Numbers: 42836-1603
Distribution
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