FDA-Device2024-09-18Class II
Medline Convenience kits labeled as: 1) LAVH CDS, Pack Number CDS760049AB; 2) TUBAL LIGATION CDS, Pack Number CDS760053D ; 3) TUBAL LIGATION CDS, Pack Number CDS760053G ; 4) TUBAL LIGATION CDS, Pack Number CDS760053I ; 5) TUBAL LIGATION CDS, Pack Number CDS760053J ; 6) GYN LAPAROSCOPY-LF, Pack Number CDS760059F ; 7) GYN LAPAROSCOPY-LF, Pack Number CDS760059G ; 8) GYN LAPAROSCOPY-LF, Pack Number CDS760059I ; 9) GYN LAPAROSCOPY-LF, Pack Number CDS760059J ; 10) LIVER TRANSPLANT #57 CDS-2
MEDLINE INDUSTRIES, LP - Northfield
Hazard
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Sold states
Worldwide distribution.
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline Convenience kits labeled as: 1) LAVH CDS, Pack Number CDS760049AB; 2) TUBAL LIGATION CDS, Pack Number CDS760053D ; 3) TUBAL LIGATION CDS, Pack Number CDS760053G ; 4) TUBAL LIGATION CDS, Pack Number CDS760053I ; 5) TUBAL LIGATION CDS, Pack Number CDS760053J ; 6) GYN LAPAROSCOPY-LF, Pack Number CDS760059F ; 7) GYN LAPAROSCOPY-LF, Pack Number CDS760059G ; 8) GYN LAPAROSCOPY-LF, Pack Number CDS760059I ; 9) GYN LAPAROSCOPY-LF, Pack Number CDS760059J ; 10) LIVER TRANSPLANT #57 CDS-2, Pack Number CDS860063R ; 11) GYN LAP , Pack Number CDS860087L ; 12) GYN LAPAROSCOPY CDS , Pack Number CDS860119Q ; 13) GYN LAPAROSCOPY CDS , Pack Number CDS860119R ; 14) GYN LAPAROSCOPY CDS , Pack Number CDS860119S ; 15) GYN LAPAROSCOPY CDS , Pack Number CDS860119U ; 16) GYN LAPAROSCOPY-LF, Pack Number CDS920074X ; 17) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099Q ; 18) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099R ; 19) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099S ; 20) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099SH; 21) GYN LAPAROSCOPY CDS-LF, Pack Number CDS920105D ; 22) GYN LAPAROSCOPY CDS-LF, Pack Number CDS920105F ; 23) GYN LAPAROSCOPY CDS-LF, Pack Number CDS920105I ; 24) GYN LAPAROSCOPY CDS , Pack Number CDS920124J ; 25) LAVH CDS, Pack Number CDS920130J ; 26) GYN LAPAROSCOPY CDS , Pack Number CDS930198S ; 27) GYN LAPAROSCOPY CDS , Pack Number CDS930198T ; 28) GYN LAPAROSCOPY CDS , Pack Number CDS930198U ; 29) GYN LAPAROSCOPY CDS , Pack Number CDS930198V ; 30) GYN LAPAROSCOPY CDS , Pack Number CDS930198W ; 31) GYN LAPAROSCOPY CDS , Pack Number CDS930198X ; 32) GYN LAPAROSCOPIC, Pack Number CDS930224I ; 33) GYN LAPAROSCOPY PROCEDURE-LF, Pack Number CDS980258S ; 34) GYN LAPAROSCOPY PROCEDURE-LF, Pack Number CDS980258T ; 35) GYN LAPAROSCOPY PROCEDURE-LF, Pack Number CDS980258U ; 36) ROBOTIC , Pack Number CDS980523M ; 37) ROBOTIC GYN , Pack Number CDS980647K ; 38) GYN LAP PROCEDURE , Pack Number CDS980810O ; 39) GYN LAP PROCEDURE , Pack Number CDS980810P ; 40) GYN LAP PROCEDURE , Pack Number CDS980810Q ; 41) GYN LAPAROSCOPY , Pack Number CDS980843G ; 42) GYN LAPAROSCOPY , Pack Number CDS980843I ; 43) DAVINCI PROCEDURE , Pack Number CDS980864O ; 44) DAVINCI PROCEDURE , Pack Number CDS980864P ; 45) GYN MAJOR CDS , Pack Number CDS980998J ; 46) GYN MAJOR , Pack Number CDS980998L ; 47) GYN ENDOSCOPY KIT , Pack Number CDS981309P ; 48) GYN ENDOSCOPY KIT , Pack Number CDS981309Q ; 49) GYN ENDOSCOPY KIT , Pack Number CDS981309T ; 50) PELVISCOPY CDS, Pack Number CDS981546F ; 51) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583R ; 52) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583S ; 53) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583T ; 54) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583U ; 55) GYN DAVINCI CDS , Pack Number CDS981606F ; 56) ROBOTIC PACK-LF , Pack Number CDS981757Q ; 57) GYN LAPAROSCOPY CDS , Pack Number CDS981880R ; 58) GYN LAPAROSCOPY CDS , Pack Number CDS981880S ; 59) GYN LAPAROSCOPY CDS , Pack Number CDS981880T ; 60) GYN LAPAROSCOPY CDS , Pack Number CDS981880U ; 61) GYN LAPAROSCOPY CDS , Pack Number CDS981880V ; 62) GYN LAPAROSCOPY CDS , Pack Number CDS981880W ; 63) GYN LAPAROSCOPY CDS , Pack Number CDS981880X ; 64) ROBOTIC CDS , Pack Number CDS981882W ; 65) ROBOTIC CDS , Pack Number CDS981882X ; 66) LITHOTOMY CDS , Pack Number CDS981897S ; 67) LITHOTOMY CDS , Pack Number CDS981897T ; 68) GYN LAPAROSCOPY CDS-LF, Pack Number CDS981988I ; 69) GYN LAPAROSCOPY , Pack Number CDS982032U ; 70) GYN LAPAROSCOPY , Pack Number CDS982032V ; 71) GYN LAPAROSCOPY , Pack Number CDS982032W ; 72) GYN LAPAROSCOPY , Pack Number CDS982032X ; 73) GYN LAPAROSCOPY , Pack Number CDS982032Y ; 74) ROBOTIC , Pack Number CDS982046V ; 75) ROBOTIC MAJOR , Pack Number CDS982046X ; 76) ROBOTIC MAJOR , Pack Number CDS982046Y ; 77) LIVER PROCEDURE , Pack Number CDS982106J ; 78) ROBOTIC PROCEDURE , Pack Number CDS982128P ; 79) GYN LAPAROSCOPY CDS , Pack Number CDS982245K ; 80
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3046-2024Don't want to check this manually?
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