Neurological surgical kits may have compromised packaging sterility
Stradis Medical is recalling Surgicare Neuro Pack neurological kits because the outer bag may be perforated or torn, potentially compromising product sterility. 176 units were distributed in Indiana, Texas, and Pennsylvania.
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: This is a Class II FDA recall involving a potential breach of sterility on surgical instruments. While no illnesses or injuries have been reported, compromised sterility on neurological surgical kits presents a significant risk of patient harm, fitting the 'risk-of-harm' category where injury has not yet been reported.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling 176 units of the Surgicare Neuro Pack - Neurological Kit due to a packaging defect. The outer bag may be perforated or torn, which could compromise the sterility of the surgical instruments contained within.
Affected products were distributed nationwide in Indiana, Texas, and Pennsylvania. The recall includes multiple lot numbers (20143461101, 20156461682, 20217462972, 20309467143, 20343467142, 20364467508, 20364468264, 21076471300, 21082471463, 21102472013, 21117472929, 21126473545) with SKU 570-2224 and UDI H65257022240.
A breach in the outer bag could allow contamination of the sterile surgical instruments, potentially exposing patients to infection or other complications during neurological procedures. Healthcare facilities that have received these kits should identify affected lot numbers and discontinue use. Contact Stradis Medical, LLC for instructions on product replacement or disposal.
The recalled product
- Product
- Surgicare Neuro Pack - Neurological Kit
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Category
- Medical Device — Surgical Kit
- Affected units
- 176
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 (13)
- SKU/Part Number 570-2224
- UDI H65257022240 Lot Numbers: 20143461101
- 20156461682
- 20217462972
- 20309467143
- 20343467142
- 20364467508
- 20364468264
- 21076471300
- 21082471463
- 21102472013
- 21117472929
- 21126473545
Distribution
Part of a larger recall action
This product is one of 5 recalled by Stradis Medical, LLC dba Stradis Healthcare 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.
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