Sterilmed recalls reprocessed St. Jude Medical Agilis NxT Steerable Introducers
Sterilmed Inc is recalling 112 reprocessed St. Jude Medical Agilis NxT Steerable Introducers due to inadequate seals caused by missing adhesive glue.
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: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Inadequate seal due to lack of adhesive glue"
Plain-English summary
Sterilmed Inc is recalling 112 units of reprocessed St. Jude Medical Agilis NxT Steerable Introducers. The devices are identified by Model Numbers STJ408309, STJ408310, and STJ408324, with expiration dates of 05/31/2018 or prior. The recall covers specific lot numbers listed in the agency's structured data.
The recall is being issued because the devices have an inadequate seal due to a lack of adhesive glue. These reprocessed devices are indicated for single use only and are intended to be sterile. The steerable introducer sheaths are used to introduce various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
The affected devices were distributed nationwide in the United States, specifically in the states of Arkansas, Colorado, Florida, Michigan, Ohio, Texas, and Washington. Users should stop using the recalled devices and contact Sterilmed Inc for further instructions.
The recalled product
- Product
- St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile. Product Usage: The reprocessed steerable introducer…
- Manufacturer
- Sterilmed Inc
- Category
- Medical Device — Cardiovascular
- Affected units
- 112
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)
- Model No. STJ408309
- STJ408310
- STJ408324. Exp. Date of 05/31/2018 or PRIOR. All Lots
- known lots: 7344024
- 7343120
- 7343643
- 7343797
- 7348305
- 7355750
- 7348712
- 7290257
- 7354522
- 7354523
- 7350001
- 7324499
- 7343501
- 7351203
- 7255673
- 7273483
- 7343603
Distribution
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