3 Liter Latex-Free Breathing Bag; Reservoir Bag; Vendor Part Number: 720057B, Medline Item Number: 40053; Available in various Anesthesia Circuit Kits and Complete Delivery System Kits including: 1) Item Number DYNJ09422, Anesthesia Kit-LF; 2) Item Number DYNJAA9010A, Anesthesia Circuit Adult Expand; 3) Item Number 00-GS2675K, Pacemaker Kit; 4) Item Number ACC010004A, Anesthesia Drawer 6; 5) Item Number ACC010015, Anesthesia Drawer 8; 6) Item Number ACC010015A, Anesthesia Drawer 8; 7) Item Number ACC010031, Anesthesia Case Cart Drawer 6; 8) Item Number ACC010036, Anesthesia Drawer 6; 9) Item Number ACC010056, Anesthesia Cart Drawer 6; 10) Item Number CDS760048M, D&C CDS; 11) Item Number CDS760050L, Vag Hyster CDS; 12) Item Number CDS760054F, Laparoscopy CDS; 13) Item Number CDS780080J, Major Spinal CDS; 14) Item Number CDS780081G, Minor Spine CDS-LF; 15) Item Number CDS780127C, Lumbar CDS; 16) Item Number CDS780150A, Craniotomy CDS-LF; 17) Item Number CDS780151A, Spinallami-Fusion-Disk-Lumb-LF; 18) Item Number CDS840144B, Open Heart CDS; 19) Item Number CDS840270C, Carotid CDS; 20) Item Number CDS840325B, Major Vascular CDS; 21) Item Number CDS840336A, Heart-LF; 22) Item Number CDS840337A, Vascular Minor CDS-LF; 23) Item Number CDS840338A, Carotid Endarectomy CDS-LF; 24) Item Number CDS840384A, Open Heart CDS; 25) Item Number CDS840429, Arrowhead Open Heart CDS; 26) Item Number CDS840463A, Accessory Pack; 27) Item Number CDS840494, AV Fistula CDS; 28) Item Number CDS860094C, Laparoscopic Colon Resection; 29) Item Number CDS860109A, Laparoscop Bilat Tubal Lig-LF; 30) Item Number CDS860159, Major ABD Procedure CDS-Pack A; 31) Item Number CDS860159A, Major ABD Procedure CDS; 32) Item Number CDS860160A, Minor ABD Procedure CDS; 33) Item Number CDS860161, Lithotomy Major CDS; 34) Item Number CDS860161A, Lithotomy Major CDS; 35) Item Number CDS860200, Lap Appy Kit; 36) Item Number CDS860200A, Lap Appy Kit; 37) Item Number CDS860201, Lap Chole Kit; 38) Item Number CDS860201A, Lap Chole Kit; 39) Item Number CDS860202, Lap Nissen Kit; 40) Item Number CDS860202A, Lap Nissen Kit; 41) Item Number CDS920108C, Laparoscopy CDS; 42) Item Number CDS930145C, Lap Chole CDS; 43) Item Number CDS930178F, Lap Chole Somc CDS-LF; 44) Item Number CDS930183A, Lap Chole CDS-LF; 45) Item Number CDS930208B, Lap Chole CDS; 46) Item Number CDS940836B, Shoulder CDS; 47) Item Number CDS940836C, Shoulder CDS; 48) Item Number CDS940837B, Knee CDS; 49) Item Number CDS940844C, Shoulder Arthroscopy CDS; 50) Item Number CDS940859C, Arthroscopy CDS-LF; 51) Item Number CDS940896F, Arthroscopy CDS; 52) Item Number CDS940900F, Shoulder CDS; 53) Item Number CDS941067A, Knee Replacement Total-LF; 54) Item Number CDS941068B, Total Hip CDS-LF; 55) Item Number CDS941248, Extremity Ortho CDS; 56) Item Number CDS941248A, Extremity Ortho CDS; 57) Item Number CDS941325, Dr Zeegan Total Hip Encino; 58) Item Number CDS941326, Dr Zeegan Total Hip Encino; 59) Item Number CDS980153B, Basic CDS; 60) Item Number CDS980211C, O.R. Turnover Kit; 61) Item Number CDS980228K, Breast Biopsy CDS; 62) Item Number CDS980232L, Plastic CDS; 63) Item Number CDS980395, D&C/Vaginal Minor CDS-LF; 64) Item Number CDS980510D, Neuro Associates Laminectomy; 65) Item Number CDS980701, Shoulder Arthroscopy Procedure; 66) Item Number CDS980702, Knee Arthroscopy Procedure; 67) Item Number CDS980703, Extremity Procedure; 68) Item Number CDS980704, Spine Procedure; 69) Item Number CDS980749, Minor CDS; 70) Item Number CDS980794, Lithotomy CDS; 71) Item Number CDS980796, Knee Arthroscopy CDS; 72) Item Number CDS980797, Gyn Abd CDS; 73) Item Number CDS980798, C-Section CDS; 74) Item Number CDS980799, Lap Chole CDS; 75) Item Number CDS980800, Hand CDS-Dr Casey; 76) Item Number CDS980801A, Lap Gastric CDS; 77) Item Number CDS980817, Total Hip CDS; 78) Item Number CDS980818, AV Fistula CDS; 79) Item Number CDS980819, Knee Arthroscopy CDS; 80) Item Number CDS980820, Shoulder Arthroscopy CDS; 81) Item Number CDS980821
Recall
- Recall Number
- Z-1163-2008
- Event Number
- 46280
- Firm
- Medline Industries Inc
- FEI Number
- 1417592
- Product Code
- BTC
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- December 7, 2007
- Posted
- June 25, 2008
- Terminated
- October 16, 2008
- Address
- 1 Medline Pl, Mundelein, IL, 60060-4486
Description
3 Liter Latex-Free Breathing Bag; Reservoir Bag; Vendor Part Number: 720057B, Medline Item Number: 40053; Available in various Anesthesia Circuit Kits and Complete Delivery System Kits including: 1) Item Number DYNJ09422, Anesthesia Kit-LF; 2) Item Number DYNJAA9010A, Anesthesia Circuit Adult Expand; 3) Item Number 00-GS2675K, Pacemaker Kit; 4) Item Number ACC010004A, Anesthesia Drawer 6; 5) Item Number ACC010015, Anesthesia Drawer 8; 6) Item Number ACC010015A, Anesthesia Drawer 8; 7) Item Number ACC010031, Anesthesia Case Cart Drawer 6; 8) Item Number ACC010036, Anesthesia Drawer 6; 9) Item Number ACC010056, Anesthesia Cart Drawer 6; 10) Item Number CDS760048M, D&C CDS; 11) Item Number CDS760050L, Vag Hyster CDS; 12) Item Number CDS760054F, Laparoscopy CDS; 13) Item Number CDS780080J, Major Spinal CDS; 14) Item Number CDS780081G, Minor Spine CDS-LF; 15) Item Number CDS780127C, Lumbar CDS; 16) Item Number CDS780150A, Craniotomy CDS-LF; 17) Item Number CDS780151A, Spinallami-Fusion-Disk-Lumb-LF; 18) Item Number CDS840144B, Open Heart CDS; 19) Item Number CDS840270C, Carotid CDS; 20) Item Number CDS840325B, Major Vascular CDS; 21) Item Number CDS840336A, Heart-LF; 22) Item Number CDS840337A, Vascular Minor CDS-LF; 23) Item Number CDS840338A, Carotid Endarectomy CDS-LF; 24) Item Number CDS840384A, Open Heart CDS; 25) Item Number CDS840429, Arrowhead Open Heart CDS; 26) Item Number CDS840463A, Accessory Pack; 27) Item Number CDS840494, AV Fistula CDS; 28) Item Number CDS860094C, Laparoscopic Colon Resection; 29) Item Number CDS860109A, Laparoscop Bilat Tubal Lig-LF; 30) Item Number CDS860159, Major ABD Procedure CDS-Pack A; 31) Item Number CDS860159A, Major ABD Procedure CDS; 32) Item Number CDS860160A, Minor ABD Procedure CDS; 33) Item Number CDS860161, Lithotomy Major CDS; 34) Item Number CDS860161A, Lithotomy Major CDS; 35) Item Number CDS860200, Lap Appy Kit; 36) Item Number CDS860200A, Lap Appy Kit; 37) Item Number CDS860201, Lap Chole Kit; 38) Item Number CDS860201A, Lap Chole Kit; 39) Item Number CDS860202, Lap Nissen Kit; 40) Item Number CDS860202A, Lap Nissen Kit; 41) Item Number CDS920108C, Laparoscopy CDS; 42) Item Number CDS930145C, Lap Chole CDS; 43) Item Number CDS930178F, Lap Chole Somc CDS-LF; 44) Item Number CDS930183A, Lap Chole CDS-LF; 45) Item Number CDS930208B, Lap Chole CDS; 46) Item Number CDS940836B, Shoulder CDS; 47) Item Number CDS940836C, Shoulder CDS; 48) Item Number CDS940837B, Knee CDS; 49) Item Number CDS940844C, Shoulder Arthroscopy CDS; 50) Item Number CDS940859C, Arthroscopy CDS-LF; 51) Item Number CDS940896F, Arthroscopy CDS; 52) Item Number CDS940900F, Shoulder CDS; 53) Item Number CDS941067A, Knee Replacement Total-LF; 54) Item Number CDS941068B, Total Hip CDS-LF; 55) Item Number CDS941248, Extremity Ortho CDS; 56) Item Number CDS941248A, Extremity Ortho CDS; 57) Item Number CDS941325, Dr Zeegan Total Hip Encino; 58) Item Number CDS941326, Dr Zeegan Total Hip Encino; 59) Item Number CDS980153B, Basic CDS; 60) Item Number CDS980211C, O.R. Turnover Kit; 61) Item Number CDS980228K, Breast Biopsy CDS; 62) Item Number CDS980232L, Plastic CDS; 63) Item Number CDS980395, D&C/Vaginal Minor CDS-LF; 64) Item Number CDS980510D, Neuro Associates Laminectomy; 65) Item Number CDS980701, Shoulder Arthroscopy Procedure; 66) Item Number CDS980702, Knee Arthroscopy Procedure; 67) Item Number CDS980703, Extremity Procedure; 68) Item Number CDS980704, Spine Procedure; 69) Item Number CDS980749, Minor CDS; 70) Item Number CDS980794, Lithotomy CDS; 71) Item Number CDS980796, Knee Arthroscopy CDS; 72) Item Number CDS980797, Gyn Abd CDS; 73) Item Number CDS980798, C-Section CDS; 74) Item Number CDS980799, Lap Chole CDS; 75) Item Number CDS980800, Hand CDS-Dr Casey; 76) Item Number CDS980801A, Lap Gastric CDS; 77) Item Number CDS980817, Total Hip CDS; 78) Item Number CDS980818, AV Fistula CDS; 79) Item Number CDS980819, Knee Arthroscopy CDS; 80) Item Number CDS980820, Shoulder Arthroscopy CDS; 81) Item Number CDS980821
Separation from Bushing: The breathing bag may separate from the bushing during use.
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.
Nationwide Distribution.
436,750 bags