smiths medical portex, Thermovent 1200, 15mm/22mm: a) RE... (Smiths Medical ASD Inc.) – uncertainty in the seal integrity of ... (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS
Brand
Smiths Medical ASD Inc.
Lot Codes / Batch Numbers
a) REF 100/582/000: 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, b) REF 100/582/000JP: UDI /DI 35019315018156, Lot Numbers: 4109285, 4109287, 4119729, 4131584, 4135055, 4135056, 4135057, c) REF 100/582/000JS: UDI/DI 35019315018156, Lot Numbers: 4135057
Products Sold
a) REF 100/582/000: 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; b) REF 100/582/000JP: UDI /DI 35019315018156, Lot Numbers: 4109285, 4109287, 4119729, 4131584, 4135055, 4135056, 4135057; c) REF 100/582/000JS: UDI/DI 35019315018156, Lot Numbers: 4135057
Smiths Medical ASD Inc. is recalling smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) RE due to Uncertainty in the seal integrity of the sterile packaging.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Uncertainty in the seal integrity of the sterile packaging.
Recommended Action
Per FDA guidance
Smiths medical issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 07/18/2024 via traceable mailing. The notice explained the issue with the products, potential risk and requested the affected devices be destroyed. Distributors were directed to notify their customers by forwarding the notice. Questions - contact smithsmedical.@sedgwick.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026