Stradis Healthcare Neonatal PICC Trays recalled for potential sterility breach
Stradis Healthcare is recalling 2,500 units of Neonatal PICC Trays due to potential pinhole leaks in the outer bag that could compromise sterility. The affected trays were distributed nationwide.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is a potential sterility breach in a medical device used in vulnerable neonatal patients, creating a clear risk of harm, but no actual injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Stradis Healthcare is recalling Neonatal PICC Trays (Assembly Number MAG-3000) due to a potential defect in the packaging. The recalled product includes 2,500 units distributed nationwide in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, and WA. Affected lot numbers are: 220883387, 221226000, 220960490, 220986568, 222074682, and 222458932.
The defect is the potential for pinhole leaks in the outer bag near the seal, which may result in a breach in the sterility of the kit. A compromise in sterility could allow contamination during use.
The recalled product
- Product
- Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufactured by Stradis Healthcare, Distributed by Med Alliance Group
- Manufacturer
- Stradis Healthcare
- Affected units
- 2,500
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 (8)
- Assembly Number MAG-3000
- UDI-DI: M752MAG30001
- Lot Numbers: 220883387
- 221226000
- 220960490
- 220986568
- 222074682
- 222458932
Distribution
Part of a larger recall action
This product is one of 18 recalled by 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.
See all 18 products in this recall →Related recalls
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