—#67115

Product

2 Liter Latex-Free Breathing Bag; Reservoir Bag; Vendor Part Number: 720058B, Medline Item Number: 40054; Available in various Anesthesia Circuit Kits and Complete Delivery System Kits including: 1) Item Number CDS980652A, Thoracic Anesthesia Pack; 2) Item Number CDS980955, Affinity Shoulder Arthroscopy; 3) Item Number CDS980956, Affinity Total Hip CDS; 4) Item Number CDS980957, Affinity Total Knee CDS; 5) Item Number DYNJAA4758B, Circuit Adult Anesthesia; 6) Item Number DYNJAA4777, Adult 40in Anesth w/HME-LF; 7) Item Number DYNJAA9796, Anes Circuit 90in EXP Adult-LF; 8) Item Number DYNJAA9847A, Adult Circuit; 9) Item Number DYNJAA9904, Circuit Adult Anesthesia; 10) Item Number DYNJAA9904A, Circuit Adult Anesthesia; 11) Item Number DYNJAA9906, Circuit Adult Anesthesia; 12) Item Number DYNJAA9933, Anesthesia Super Circuit; 13) Item Number DYNJAAF6318A, Adult Anesthesia Circuit; 14) Item Number DYNJAP4726, Pedi Circuit 40in; 15) Item Number DYNJAP4737A, Circuit Pediatric Anesthesia; 16) Item Number DYNJAP4737B, Circuit Pediatric Anesthesia; 17) Item Number DYNJAP4737C, Circuit Pediatric Anesthesia; 18) Item Number DYNJAP4744, Pediatric Anesthesia Circuit; 19) Item Number DYNJAP6138, Circuit Pediatric Anesthesia; 20) Item Number DYNJAP7258, Circuit Pediatric Anesthesia; 21) Item Number DYNJAP7259, Peds Anesthesia Circuit; 22) Item Number DYNJAPF6007, Circuit Ped Uni 60in-LF; 23) Item Number DYNJAPF6012, Circuit Pediatric Anesthesia. Medline Industries Inc., Mundelein, IL 60060.

FDA product code: BTC — Bag, Reservoir
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: 2 liter bag, Vendor Part Number: 720058B, Medline Item Number: 40054, all lots manufactured after October 2006, packaged in the following kits: 1) Item Number: CDS980652A, Lot Number(s): 07JD0594; 2) Item Number: CDS980955, Lot Number(s): 07KD0352; 3) Item Number: CDS980956, Lot Number(s): 07KD0281; 4) Item Number: CDS980957, Lot Number(s): 07KD0282; 5) Item Number: DYNJAA4758B, Lot Number(s): 07DD2346, 07ID2931 and 07KB2367; 6) Item Number: DYNJAA4777, Lot Number(s): 07DD2800, 07DD4133, 07ID3130, 07JB1784, 07KB3600; 7) Item Number: DYNJAA9796, Lot Number(s): 07DD1377, 07DD2347, 07GD1504, 07ID3383, 07JB2589 8) Item Number: DYNJAA9847A, Lot Number(s): 07FD0840, 07FD3218, 07ID2679 and 07KB1977; 9) Item Number: DYNJAA9904, Lot Number(s): 07ED1416, 07ED3547 and 07FD1256; 10) Item Number: DYNJAA9904A, Lot Number(s): 07JB2027; 11) Item Number: DYNJAA9906, Lot Number(s): 07DD2538 and 07FD0568; 12) Item Number: DYNJAA9933, Lot Number(s): 07JD1295 and 07KD2315; 13) Item Number: DYNJAAF6318A, Lot Number(s): 07ID3358, 07JD0005 and 07KD3034; 14) Item Number: DYNJAP4726, Lot Number(s): 07DD1381 and 07KD1419; 15) Item Number: DYNJAP4737A, Lot Number(s): 07AD0945; 16) Item Number: DYNJAP4737B, Lot Number(s): 07DD2005; 17) Item Number: DYNJAP4737C, Lot Number(s): 07ID3877 and 07KD2238; 18) Item Number: DYNJAP4744, Lot Number(s): 07GD1491; 19) Item Number: DYNJAP6138, Lot Number(s): 07ID3357; 20) Item Number: DYNJAP7258, Lot Number(s): 07KB4822; 21) Item Number: DYNJAP7259, Lot Number(s): 07GD1121 and 07JD0740; 22) Item Number: DYNJAPF6007, Lot Number(s): 07GD1295; 23) Item Number: DYNJAPF6012, Lot Number(s): 07DD3724

Why it was recalled

Separation from Bushing: The breathing bag may separate from the bushing during use.

Root cause (FDA determination)

Device Design

Action the firm took

Consignees were notified by a Sub-Recall Notice letter sent on 12/5/07. The letter instructed users to check their inventory for any affected product and to return a response card indicating the quantity of affected product. The users were instructed to return the affected products to the recalling firm so that they can be reworked. Users who did not wish to return the affected products could request a replacement product and were instructed to destroy the affected products. The letter also informed users that affected products in the manufacturer's inventory were being replaced and these replaced products would contain the label "INSPECTED." For additional information, contact 1-866-359-1704.

Recalling firm

Firm: Medline Industries Inc
Address: 1 Medline Pl, Mundelein, Illinois 60060-4486

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2007-12-07
Posted by FDA: 2008-06-25
Terminated: 2008-10-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #67115. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.