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FlexPro® PenMate®

NOVO NORDISK INC. · Model 771290 · UDI-DI 00301697712901

KZH
10
510(k) clearances
1,079
Adverse events (1 deaths)
10
Recalls
40
Facilities

Description

Auto-insertion accessory only for Norditropin® FlexPro® 5 mg/1.5 mL, 10 mg/1.5 mL and 15 mg/1.5 mL prefilled pens. Designed and intended for use with Novo Nordisk® disposable needles.

Recalls

DateFirmReason
2019-07-17Owen Mumford USA, Inc.There is a possible assembly error on Autoject EI, lot number V14. This lot was packed into two products: AJ 1310, lot number V14 and AN 3310VET (branded as Petfine Auto Injector)
2019-07-17Owen Mumford USA, Inc.There is a possible assembly error on Autoject EI, lot number V14. This lot was packed into two products: AJ 1310, lot number V14 and AN 3310VET (branded as Petfine Auto Injector)
2017-06-23International Medsurg Connection, Inc.Insufficient documentation to support product sterility claims.
2014-11-24Owen Mumford USA, Inc.The syringe carrier is missing components: a damper and spring.
2011-06-15Becton Dickinson & CompanyExperiment labels may be on shelf cartons of 1.0ml 28G x 1/2 blister packaged insulin syringes.
2005-03-08Tri-State Hospital Supply CorpSome of the needles in these sets are 3/4 inches in length instead of the labeled 1 inch.
2003-10-22Arrow International Incpackage lid identifies the contents incorrectly
2003-09-16Arrow International Incwrong product in box
2003-09-16Arrow International Incwrong product in box
2003-09-16Arrow International Incwrong product in box

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.