Medical device kits recalled due to potential sterility failure
Medline Industries is recalling IV securement kits and neonatal PICC line insertion trays due to potential lack of sterility in Nurse Assist components. Approximately 11,812 units are affected.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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: This recall is classified by the FDA as Class I, the highest classification for medical devices, which mandates a minimum severity score of 4. Non-sterile medical irrigation components in IV securement and PICC line insertion products pose a significant risk of infection and contamination.
Plain-English summary
Medline Industries, LP is recalling certain IV securement kits and neonatal PICC line insertion trays because they were manufactured with specific lots of Nurse Assist medical irrigation components that may lack sterility. The affected Nurse Assist products include 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe. If these components are non-sterile, they could contaminate the final product.
The recalled Medline products include: IV SECUREMENT KIT (REF IVS1860B, Lot Nos. 2022041880, 2022082280); NEONATAL PICC LINE INSERTION TRAY (REF CVI2025, Lot No. 2022053190); NEONATAL PICC LINE INSERTION TRAY (REF CVI4570, Lot Nos. 2022042690, 2022072590, 2022103190, 2023041290, 2023051090); and SECONDARY IV START KIT (REF IV8695A, Lot Nos. 2021121750, 2022030780). Approximately 11,812 units are affected.
The products were distributed throughout the United States including Puerto Rico, Canada, the United Arab Emirates, and Panama. Healthcare providers and consumers who have the recalled products should discontinue use of affected lots and contact Medline Industries for replacement or return instructions.
The recalled product
- Product
- Centurion Kits, trays, and packs labeled as follows: a) IV SECUREMENT KIT, REF IVS1860B; b) NEONATAL PICC LINE INSERTION TRAY, REF CVI2025; c) NEONATAL PICC LINE INSERTION TRAY, REF CVI4570; d) SECONDARY IV START KIT, REF IV8695A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 11,812
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 (20)
- a) REF IVS1860B
- UDI/DI 00653160351354 (case)
- 10653160351351 (unit)
- Lot Numbers: 2022041880
- 2022082280
- b) REF CVI2025
- UDI/DI 50653160060459 (case)
- 00653160060454 (unit)
- Lot Numbers: 2022053190
- c) REF CVI4570
- UDI/DI 00653160323382 (case)
- 10653160323389 (unit)
- Lot Numbers: 2022042690
- 2022072590
- 2022103190
- 2023041290
- 2023051090
- d) REF IV8695A
- UDI/DI 00653160348569 (case)
- 10653160348566 (unit)
Distribution
Part of a larger recall action
This product is one of 49 recalled by MEDLINE INDUSTRIES, LP - Northfield 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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