First Breath PEDIATRIC Medium Concentration Oxygen Mask with Tubing, 213cm (7ft) (Non-latex) 50/CA Reorder Number: 00147

FDA device recall Z-2651-2011 · posted 2011-06-24 · Terminated

Recall details

Recalling firm

Smiths Medical

Reason for recall

A sticky substance on the inside and/ or outside of the Mask

Action taken

Smiths Medical notified consignees by letter on 2/14/11 titled Urgent Medical Device Correction Notice via U.S. Mail (USA only) This Notice includes an Urgent Medical Device Correction Notice Confirmation Form that provides instructions to consignees to return unused affected product to Smiths Medical and to complete the effectivity tracking form. On 3/17/11 Smiths Medical issued an additional recall letter to extend the recall to 3 additional lots not included in the original recall letter dated 2/14/11. Also, the firm issued a recall letter on 3/17/11 to include the Value Pack (VP1302) General Anesthesia Kit to include 7 kit lots. Contact Recall Coordinator 1-800-348-6064 prompt 4, ext 2273

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

BYG

Quantity affected

1952 units

Distribution

Worldwide Distribution - USA (nationwide) and the countries of United Arab Emirates, Armenia, Brazil, Canada, France, Hungary, Italy, Jordan, Japan, Libya, Poland, Russian Federation, and Saudi Arabia

Date initiated

2011-02-11

Date posted

2011-06-24

Date terminated

2018-07-02

Location

Hythe Kent, United Kingdom