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U.S. Department of Health and Human Services

Class 2 Device Recall 2 Liter LatexFree Breathing Bag

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  Class 2 Device Recall 2 Liter LatexFree Breathing Bag see related information
Date Initiated by Firm December 07, 2007
Date Posted June 25, 2008
Recall Status1 Terminated 3 on October 16, 2008
Recall Number Z-1164-2008
Recall Event ID 46280
Product Classification Reservoir Bag - Product Code BTC
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.
Code Information 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 
Recalling Firm/
Medline Industries Inc
1 Medline Pl
Mundelein IL 60060-4486
For Additional Information Contact
Manufacturer Reason
for Recall
Separation from Bushing: The breathing bag may separate from the bushing during use.
FDA Determined
Cause 2
Device Design
Action 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.
Quantity in Commerce 57,000 bags
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.