Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure, Pack #00-RDF0360, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. b. Medline Angiography Pack, Pack #DYNJ26488W, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. c. Medline Heart Catheterization Pack, Pack #DYNJ30927Q, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000. d. Medline Heart Catheterization Pack, Pack #DYNJ30927R, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000. e. Medline Minor Special Procedure Pack, Pack #DYNJ38326G, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000. f. Medline Perm Cath Tray, Pack #DYNJ40423A, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000. g. Medline CRMC Angiogram-LF, Pack #DYNJ61082F, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000. h. Medline CRMC Minor IR Procedure Pk-LF, Pack #DYNJ61099D, containing a Pure Pouch with component Sterile Adson Forceps with Typing Platform, Reorder #66970. i. Medline CRMC Minor IR Procedure Pk-LF, Pack #DYNJ61099F, containing a Pure Pouch with component Sterile Adson Forceps with Typing Platform, Reorder #66970. j. Medline Cath Lab Pack, Pack #DYNJ81995, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000. k. Medline Cardiac Cath, Pack #DYNJ82907, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000. l. Medline Special Procedure Tray, Pack #DYNJ83626, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. m. Medline Cath Lab Pack, Pack #DYNJ83924, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000. n. Medline Cath Lab Pack, Pack #DYNJ83924A, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000. o. Medline Cath Pack, Pack #DYNJ84739, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000. p. Medline Cardiac Cath Pack, Pack #DYNJ85872, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000. q. Medline Pacemaker Pack, Pack #DYNJ55340C, containing a Pure Pouch with component Sterile Straight Kelly Hemostat, Reorder #66170. r. Medline CRMC Tunnel Cath Tray-LF, Pack #DYNJ61118G, containing a Pure Pouch with component Sterile Adson Forceps with Typing Platform, Reorder #66970. s. Medline CRMC Tunnel Cath Tray-LF, Pack #DYNJ61118I, containing a Pure Pouch with component Sterile Adson Forceps with Typing Platform, Reorder #66970. t. Medline Endovascular Pack, Pack #DYNJ66727B, containing a Pure Pouch with component Sterile 6" SnagFree Mayo Needle Holder, Reorder #66430. u. Medline Endovascular Pack, Pack #DYNJ66727C, containing a Pure Pouch with component Sterile 6" SnagFree Mayo Needle Holder, Reorder #66430. v. Medline IR Central Kit, Pack #DYNJ68285A, containing a Pure Pouch with component Sterile Curved Kelly Hemostat, Reorder #66175. w. Medline Biopsy Tray MVH, Pack #DYNJ63560B, containing a Pure Pouch with component Sterile Curved Kelly Hemostat, Reorder #66175. x. Medline FFX Drainage Tray, Pack #DYNJ82142, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000.

Reason: Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.

Code information: a. Pack #00-RDF0360 - lot numbers 24AMF652, exp. 11/30/2026, 23IMD552, exp. 6/30/2026, and 23DMI750, exp. 7/31/2025, UDI-DI each-10195327195618, UDI-DI case-40195327195619. b. Pack #DYNJ26488W - lot number 23EDA461, exp. 10/31/2025, UDI-DI each-10195327209780, UDI-DI case-40195327209781. c. Pack #DYNJ30927Q - lot numbers 23IMB725, exp. 4/30/2026, and 23GMI473, exp. 1/31/2026, UDI-DI each-10195327164225, UDI-DI case-40195327164226. d. Pack #DYNJ30927R - lot numbers 23LMH572, exp. 5/31/2026, 23KMH917, exp. 6/30/2026, 23KMD083, exp. 5/31/2026, and 23KMB895,exp. 10/31/2025, UDI-DI each-10195327539160, UDI-DI case-40195327539161. e. Pack #DYNJ38326G - lot numbers 23KMB384, exp. 5/3/2025, and 23HME988, exp. 5/31/2025, UDI-DI each 10195327230135, UDI-DI case-40195327230136. f. Pack #DYNJ4423A - lot number 23JBC229, exp. 8/31/2027, UDI-DI each-10889942346998, UDI-DI case-40889942346999. g. Pack #DYNJ61082F - lot numbers 23HMG768, exp. 3/31/2026, UDI-DI each-10195327451783, UDI-DI case-40195327451784. h. Pack #DYNJ61099D - lot numbers 23JBN632, exp. 1/31/2026, UDI-DI each-10195327451790, UDI-DI case-40195327451791. i. Pack #DYNJ61099F - lot numbers 24ABB295, exp. 4/30/2026, UDI-DI each-10195327561925, UDI-DI case-40195327561926. j. Pack #DYNJ81995 - lot numbers 23JMA624, exp. 8/31/2026, and 23GME739, exp. 4/30/2026, UDI-DI each-10195327163471, UDI-DI case 40195327163472. k. Pack #DYNJ82097 - lot number 23GME848, exp. 7/31/2025, UDI-DI each-10195327169701, UDI-DI case-40195327169702. l. Pack #DYNJ83626 - lot numbers 24AMG191, exp. 11/30/2026, 23HME813, exp. 2/28/2026, and 23EMI882, exp. 2/28/2026, UDI-DI each-10195327286873, UDI-DI case 40195327286874. m. Pack #DYNJ83924 - lot numbers 23FBH281, exp. 7/31/2027, UDI-DI each-10195327314835, UDI-DI case-40195327314836. n. Pack #DYNJ83924A - lot numbers 23KBQ984, exp. 1/31/2028, and 23KBN818, exp. 1/31/2028, UDI-DI each-10195327507206, UDI-DI case-40195327507207. o. Pack DYNJ84739 - lot numbers 23KMG773, exp. 8/31/2026, and 23JMB674, exp. 2/28/2025, UDI-DI each-10195327409272, UDI-DI case-40195327409273. p. Pack DYNJ85872 - lot number 24BBB337, exp. 9/30/2026, UDI-DI each-10195327562724, UDI-DI case-40195327562725. q. Pack DYNJ55340C - lot number 23FMC559, exp. 9/30/2025, UDI-DI each-10195327352912, UDI-DI case 40195327352913. r. Pack #DYNJ61118G - lot numbers 23JME718, exp. 5/31/2025, and 23GME956, exp. 5/31/2026, UDI-DI each-10195327451745, UDI-DI case-40195327451746. s. Pack #DYNJ61118I - lot number 23KMG830, exp. 5/31/2025, UDI-DI each-10195327561918, UDI-DI case 40195327561919. t. Pack #DYNJ66727B - lot numbers 23GBT746, exp. 4/30/2024, 23FBM310, exp. 5/31/2024, and 23EBJ690, exp. 2/29/2024, UDI-DI each-10195327299088, UDI-DI case-40195327299089. u. Pack #DYNJ66727C - lot number 23JBV616, exp. 6/30/2024, UDI-DI each-10195327511135, UDI-DI case-40195327511136. v. Pack #DYNJ68285A - lot number 23DMH178, exp. 7/31/2025, UDI-DI each-10193489878653, UDI-DI case-40193489878654. w. Pack #DYNJ63560B - lot numbers 23LLA770, exp. 3/31/2025, 23JLA771, exp. 1/31/2025, and 23ILA367, exp. 1/31/2025, UDI-DI each-10193489417500, UDI-DI case-40193489417501. x. Pack #DYNJ82142 - lot numbers 23HLB135, exp. 2/28/2026, and 23GLA498, exp. 4/30/2025, UDI-DI each-10195327177874, UDI-DI case-40195327177875. y. Pack #DYNJ47873L - lot numbers 23KBW512, exp. 8/31/2027, UDI-DI each-10195327506896, UDI-DI case-40195327506897. z. Pack #DYNJ56073C - lot numbers 23IDA509, exp. 5/31/2026, and 23DDC159, exp. 11/30/2025, UDI-DI each-10193489441833, UDI-DI case-40193489441834.

Distribution pattern: US Nationwide distribution in the states of AL, CA, CO, CT, FL, IL, IN, MD, MN, MT, NC, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, and WY.