Moderate riskFDA DeviceClass II

Integrated MedCraft FORWARD airway kits recalled for blocked tip

Integrated MedCraft LLC is recalling specific lots of its FORWARD Oral Airway Kit and certain Guedel airway components because the airway tip may be blocked or partly blocked. No injuries have been reported. About 509 units were distributed across the US.

From the FDA notice · Read the official notice ↗

What to do

  1. Check the REF number 1011-40002 and the lot numbers on the kit or component packaging against the recall notice.
  2. If your kit or component matches a listed lot, stop using it and set it aside.
  3. Contact Integrated MedCraft LLC for instructions on the next steps, since no specific remedy has been listed.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, ISO 3.5, light green. Product Code: 1000035.
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 2 products — see all of them.

Details

Units affected
509 units
Illnesses reported
None reported
Manufactured in
1 Sinco Pl Unit A10, East Hampton, CT, United States
Classification
Class II
Recall number
Z-2836-2026

In the FDA's words

Description
FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, ISO 3.5, light green. Product Code: 1000035. Devices could potentially contain an occluded or partially occluded Guedel Airway tip. FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Lot Numbers: IMC-00000060, IMC-00000066, IMC-00000078, IMC-00000086, IMC-00000092, IMC-00000096, IMC-00000096, IMC-00000097, IMC-00000103, IMC-00000110, IMC-00000125, IMC-00000151, IMC-00000200, IMC-00000201, IMC-00000204, IMC-00000205. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. Lot Numbers: 32121232, 32208193, 32400267, 32403734, 32408819, 32409672, 32416545, 32427064, 32605471, 32606405, 32606850, 32607154. 2. Size 000, ISO 3.5, light green. Product Code: 1000035. Lot Numbers: 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565 Distribution: US Nationwide distribution. Affected quantity: 509 units
Hazard
Devices could potentially contain an occluded or partially occluded Guedel Airway tip.

2 products in this recall

FORWARD and Kingfisher airway kits recalled for possible blockage

Integrated Medcraft is recalling two first aid kits, the FORWARD Oral Airway Kit (REF 1011-40002) and the Kingfisher Compact Individual First Aid Kit (REF 76656), that contain one-piece Guedel airway components. The devices could potentially contain an occluded or partially occluded airway tip. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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