A) Product Code 2N8220: Non-DEHP Catheter Extension Set recall: Sterility Concern
A) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.7", Vol. 1.10 mL, Luer Activated Valve for IV Access…
Why was A) Product Code 2N8220: Non-DEHP Catheter Extension Set recalled?
Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
A) Product Code 2N8220: Lots R12J05070; B) Product Code 2N8221: Lots R12J20046, R12J22042; C) Product Code 2N8222: Lots R12L07031; D) Product Code 2N8223: Lots R12L06074, R12K02083; E) Product Code 6N8220: Lots R12I01054, R12H25048, R12H27192, R12J04057, R12J22109, R12L07049, R12L08088; F) Product Code 6N8222: Lots R12J15046, R12J23115
- Product
- A) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.7", Vol. 1.10 mL, Luer Activated Valve for IV Access…
- Recalling firm
- Baxter Healthcare Corp.
- Quantity
- A) Code 2N8220: 5,950; B) Code 2N8221: 6,150; C) Code 2N8222: 1,850; D) Code 2N8223: 7,900; E) Code 6N8220: 52,200; F) Code 6N8222: 1,200
- Distribution
- Worldwide Distribution - USA Nationwide and the countries of Puerto Rico, Brazil, Canada and Columbia.
- Recall date
- May 15, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)