Reported Jan 3, 2018 · Terminated
St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94…
Sterilmed Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sterilmed Inc · 5010 Cheshire Pkwy N Ste 2 · Minneapolis, MN · 55446-4101
Is this the product you have?
- St. Jude Medical
- Agilis NxT Steerable Introducer
B1-DirectionalMedium Curl 22.4 mm71 cm6.5 F ID
- Dilator
94 cm8.5 FSuper Stiff
- Guidewire180 cm, 0.032". Reprocessed device for single use only, sterile
- Product UsageThe reprocessed steerable introducer sheaths are indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum
- Lot codes and dates
- Model No. STJ408309, STJ408310, STJ408324. Exp. Date of 05/31/2018 or PRIOR. All Lots
- known lots
106 of 106 codes
734402473431207343643734379773483057355750734871272902577354522735452373500017324499734350173512037255673727348373436037355439735574573557547355752728274173155397320863734376673510387330645734514373237227330603734208173517247352687735513073551317355137737776073551357375662740430074043017404316740430673433957355463735571473556227330666735557273279997355677730833773436867355680725190372594007322815734206973555747355676
- Amount recalled
- 112 devices
Where it was sold
Why it was recalled
Stop using this product now
Inadequate seal due to lack of adhesive glue
Using this product could cause serious injury, illness or death — stop using it now.
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