Reported Oct 30, 2024 · Ongoing

smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS

Smiths Medical ASD Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

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: Smiths Medical ASD Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690

- smiths medical portex
- Thermovent 1200
- 15mm/22mm: a) REF 100/582/000
- b) REF 100/582/000JP
- c) REF 100/582/000JS

Lot codes and dates: 3 of 3 products
Products covered by this recall
Model / number Barcodes Product as published
100/582/000 35019315022405350193150109903501931501100335019315018156350193150223993501931502242935019315022559 UDI/DI 35019315022405, Lot Numbers: 4133230; UDI/DI 35019315010990, Lot Numbers: 4138707; UDI/DI 35019315011003, Lot Numbers: 4144947, 4147167; UDI/DI 35019315018156, Lot Numbers: 4135055, 4135056, 4135057, 4135059, 4135061, 4135063, 4147386, 4147387; UDI/DI 35019315022399, Lot Numbers: 4133228, 4133229; UDI/DI 35019315022429, Lot Numbers: 4141737, 4147168; UDI/DI 35019315022559, Lot Numbers: 4133814, 4147169
100/582/000JP 35019315018156 UDI /DI 35019315018156, Lot Numbers: 4109285, 4109287, 4119729, 4131584, 4135055, 4135056, 4135057
100/582/000JS 35019315018156 UDI/DI 35019315018156, Lot Numbers: 4135057
Amount recalled: 141,196 units

The agency filed one notice per product. You are reading one of them; the other 13 are below.

1 more are in the archive.

Uncertainty in the seal integrity of the sterile packaging.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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60 in total.

Model / number	Barcodes	Product as published
`100/582/000`	`35019315022405350193150109903501931501100335019315018156350193150223993501931502242935019315022559`	UDI/DI 35019315022405, Lot Numbers: 4133230; UDI/DI 35019315010990, Lot Numbers: 4138707; UDI/DI 35019315011003, Lot Numbers: 4144947, 4147167; UDI/DI 35019315018156, Lot Numbers: 4135055, 4135056, 4135057, 4135059, 4135061, 4135063, 4147386, 4147387; UDI/DI 35019315022399, Lot Numbers: 4133228, 4133229; UDI/DI 35019315022429, Lot Numbers: 4141737, 4147168; UDI/DI 35019315022559, Lot Numbers: 4133814, 4147169
`100/582/000JP`	`35019315018156`	UDI /DI 35019315018156, Lot Numbers: 4109285, 4109287, 4119729, 4131584, 4135055, 4135056, 4135057
`100/582/000JS`	`35019315018156`	UDI/DI 35019315018156, Lot Numbers: 4135057