Smiths Medical Portex Nasopharyngeal Airway recalled for sterile packaging seal integrity uncertainty
Smiths Medical ASD Inc. is recalling 251,591 Portex Nasopharyngeal Airway units worldwide due to uncertainty in sterile packaging seal integrity, potentially compromising the sterile barrier.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard—uncertainty in sterile packaging seal integrity—is a theoretical risk of contamination for a critical medical device. Per the rubric, risk-of-harm products without reported injury score at most 3 (High).
Plain-English summary
Smiths Medical ASD Inc. is recalling 251,591 units of Portex Nasopharyngeal Airway across multiple sizes (6.0mm through 9.0mm). The devices are distributed worldwide.
The recall is due to uncertainty in the seal integrity of the sterile packaging. This compromises the sterile barrier that protects the device, potentially allowing contamination during storage and transport.
Healthcare facilities and clinicians currently using or holding these devices should immediately cease use of affected units and contact Smiths Medical ASD Inc. for instructions on device return or replacement. A complete list of affected lot numbers and reference numbers is available from the manufacturer.
The recalled product
- Product
- smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060; b) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060JP; c) AIRWAY NASOPHARYNGEAL 7.0MM, REF 100/210/070; d) AIRWAY NASOPHARYNGEAL 7.0MM, REF 100/210/070JP; e)…
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 251,591
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)
- a) REF 100/210/060
- UDI/DI 35019315010990
- Lot Numbers: 4147817
- UDI/DI 35019315011003
- Lot Numbers: 4097683
- 4100700
- UDI/DI 35019315022399
- Lot Numbers: 4089149
- 4112945
- UDI/DI 35019315022405
- Lot Numbers: 4110350
- 4115879
- 4156815
- UDI/DI 35019315022429
- Lot Numbers: 4107296
- b) REF 100/210/060JP
- 4104268
- 4107295
- 4133226
- 4133228
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by Smiths Medical ASD Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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