AUTOPEN

Lot 7JH, UPC Code 384703800014

General Hospital and Personal Use Devices

2

No

Nationwide Distribution including FL, IL, NV, NJ, OH, and TN.

Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, || The product is a non-sterile automatic subcutaneous injection device which delivers insulin.

Injections / Infusions / Transfusions / Dialysis - insulin pens and pen cannulas

Medical Device Safety Alert: Owen Mumford Autopen, Autopen 24, Densupen and Autopen 3ml for Teriparatide

Autopen 24 1 unit pen Product code: AN4210. PIP code 293-5096. Autopen 24 2 unit pen. Product code: AN4200. PIP code 293-5070. Autopen Classic 1 unit pen. Product code: AN3810. PIP code 273-3178. Autopen Classic 2 unit pen. Product code: AN3800. PIP code 260-3561. To identify affected devices still within their packaging, look for the following packaging lot codes on the outer carton. Packaging lot code Product code Product name 7VJ AN3810 3ml 1 Unit Autopen Classic 7WB AN4200 Autopen 24 3ml 2 Unit 7WC AN4210 Autopen 24 3ml 1 Unit 7WD AN3800 3ml 2 Unit Autopen Classic 8CN AN4200 Autopen 24 3ml 2 Unit 8CP AN4200 Autopen 24 3ml 2 Unit 8CR AN4210 Autopen 24 3ml 1 Unit 8EL AN3800 3ml 2 Unit Autopen Classic 8EM AN3810 3ml 1 Unit Autopen Classic 8JK AN4210 Autopen 24 3ml 1 Unit 8JM AN3800 3ml 2 Unit Autopen Classic 8JN AN3810 3ml 1 Unit Autopen Classic 8JP AN4210 Autopen 24 3ml 1 Unit 8VV AN4200 Autopen 24 3ml 2 Unit 8VW AN4200 Autopen 24 3ml 1 Unit To identify affected devices without packaging look for the following production lot codes, which can be found on the lower part of the pen body. Production lot code (stamped on pen) Product code Product name 7RT AN3810 3ml 1 Unit Autopen Classic 7PN AN4200 Autopen 24 3ml 2 Unit 7PP AN4210 Autopen 24 3ml 1 Unit 7RV AN3800 3ml 2 Unit Autopen Classic 8KK AN3800 3ml 2 Unit Autopen Classic 8XD AN4200 Autopen 24 3ml 2 Unit