Class II Recall

MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH CDS, REF CDS983411J; 3) M

Summary

The FDA issued a Class II for MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056 by MEDLINE INDUSTRIES, LP - Northfield. Reason: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryke.

Details

Source

Device Recall

External ID

Z-0646-2025

Action Date

2024-12-11

Status

Ongoing

Product Description

MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH CDS, REF CDS983411J; 3) MAJOR VAGINAL, REF CDS983497L; 4) DAY SURG LARGE VAG CDS, REF CDS984995N; 5) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 6) D&C/HYSTEROSCOPY PACK, REF DYNJ01921M; 7) HYSTERECTOMY PACK-LF, REF DYNJ0488471K; 8) VAG HYST PACK-LF, REF DYNJ0532873M; 9) VAG HYST PACK-LF, REF DYNJ0532873N; 10) VAGINAL PROCEDURES PACK-LF, REF DYNJ0750737Q; 11) MINOR VAGINAL #76-RF, REF DYNJ27434R; 12) DB VAG HYSTERECTOMY-LF, REF DYNJ33590I; 13) VAG HYST PACK, REF DYNJ36628L; 14) VAG HYST PACK, REF DYNJ36628M; 15) ROBOTIC HYSTO URO PACK, REF DYNJ40623F; 16) ABDOMINAL HYST PACK, REF DYNJ44848L; 17) DA VINCI HYSTERECTOMY, REF DYNJ44863Q; 18) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900O; 19) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900P; 20) URO GYN, REF DYNJ50047G; 21) LAVH NEW BRAUNFELS, REF DYNJ61136D; 22) ABDOMINAL PERINEAL, REF DYNJ63371D; 23) ABDOMINAL HYST FFX, REF DYNJ63631A; 24) VAGINAL HYSTERECTOMY PACK, REF DYNJ67194B; 25) LAVH PACK, REF DYNJ67210A; 26) VAG MINOR PACK, REF DYNJ82216; 27) VAG MINOR PACK, REF DYNJ82216B; 28) ABDOMINAL HYSTERECTOMY, REF DYNJ900091F; 29) VAGINAL, REF DYNJ900292K; 30) GYN LAPAROTOMY, REF DYNJ900296J; 31) LAVH, REF DYNJ900298J; 32) LAVH, REF DYNJ900298K; 33) LITHOTOMY-LF, REF DYNJ900721C; 34) MAJOR VAGINAL-LF, REF DYNJ901807I; 35) ABDOMINAL HYSTERECTOMY, REF DYNJ906478F; 36) VAGINAL HYST, REF DYNJ907220A; 37) PRENTICE GYNE ONCOLOGY KIT, REF DYNJ908792; 38) PRENTICE TOTAL ABD HYST KIT, REF DYNJ908795; 39) PRENTICE TOTAL ABD HYST KIT, REF DYNJ908795B; 40) PRENTICE VAG HYST KIT, REF DYNJ908796; 41) PRENTICE VAG HYST KIT, REF DYNJ908796B; 42) KIT LAVH CENTRAL DUPAGE, REF DYNJ908825; 43) KIT PFANNENSTIEL GYN, REF DYNJ908826; 44) KIT VAGINAL HYSTERECTOMY, REF DYNJ908837

Lot/Code Info: 85OJF 1) REF CDS760056G, UDI/DI 10195327009656 (each) 40195327009657 (case), Lot Numbers: 24BBQ489, 23KBP697; 2) REF CDS983411J, UDI/DI 10195327150273 (each) 40195327150274 (case), Lot Numbers: 22LDA249, 23CDB670, 23JDA480, 23IDA660; 3) REF CDS983497L, UDI/DI 10195327560980 (each) 40195327560981 (case), Lot Numbers: 24ADA431, 24BDB524; 4) REF CDS984995N, UDI/DI 10195327587963 (each) 40195327587964 (case), Lot Numbers: 24GBH834, 24EBL666, 24ABA667, 24DBI833, 24CBU970, 24CBJ697; 5) REF DYNJ0160684F, UDI/DI 10195327304287 (each) 40195327304288 (case), Lot Numbers: 22LDB323, 22LDC130, 23CDA546; 6) REF DYNJ01921M, UDI/DI 10195327491673 (each) 40195327491674 (case), Lot Numbers: 23IBT540; 7) REF DYNJ0488471K, UDI/DI 10195327046064 (each) 40195327046065 (case), Lot Numbers: 22EBG378, 23CBQ258, 23CBA485, 23KBC614, 23HBP501, 23JBT064, 23IBV599; 8) REF DYNJ0532873M, UDI/DI 10195327083465 (each) 40195327083466 (case), Lot Numbers: 22FMH645, 22HMF692; 9) REF DYNJ0532873N, UDI/DI 10195327249694 (each) 40195327249695 (case), Lot Numbers: 23DMD053; 10) REF DYNJ0750737Q, UDI/DI 10195327196783 (each) 40195327196784 (case), Lot Numbers: 23FMC422; 11) REF DYNJ27434R, UDI/DI 10195327107727 (each) 40195327107728 (case), Lot Numbers: 22EBR089, 23ABM013, 23CBX286; 12) REF DYNJ33590I, UDI/DI 10195327469542 (each) 40195327469543 (case), Lot Numbers: 23JDA425, 23GDB694, 23JDA783; 13) REF DYNJ36628L, UDI/DI 10193489437188 (each) 40193489437189 (case), Lot Numbers: 22HMF864, 23EMB913; 14) REF DYNJ36628M, UDI/DI 10195327437268 (each) 40195327437269 (case), Lot Numbers: 23LMC975, 23LMC305, 24AMC175, 23FMD871; 15) REF DYNJ40623F, UDI/DI 10195327435783 (each) 40195327435784 (case), Lot Numbers: 23IBR215; 16) REF DYNJ44848L, UDI/DI 10195327127565 (each) 40195327127566 (case), Lot Numbers: 22IDA312, 22LDB966; 17) REF DYNJ44863Q, UDI/DI 10195327298227 (each) 40195327298228 (case), Lot Numbers: 23ADA450, 23CDC113, 23CDA613, 23BDA189; 18) REF DYNJ44900O, UDI/DI 10195327127770 (each) 40195327127771 (case), Lot Numbers: 22HDB535, 22KDB315; 19) REF DYNJ44900P, UDI/DI 10195327298548 (each) 40195327298549 (case), Lot Numbers: 22KDB784, 22LDA872, 22LDB908, 23DDA086; 20) REF DYNJ50047G, UDI/DI 10195327107734 (each) 40195327107735 (case), Lot Numbers: 22FBN014, 22LBP709, 23DBJ770, 23CBF613; 21) REF DYNJ61136D, UDI/DI 10195327470302 (each) 40195327470303 (case), Lot Numbers: 23IBN858; 22) REF DYNJ63371D, UDI/DI 10193489983784 (each) 40193489983785 (case), Lot Numbers: 22DBL296, 22FBS033; 23) REF DYNJ63631A, UDI/DI 10193489900309 (each) 40193489900300 (case), Lot Numbers: 22HBC445, 22FBR617, 22LBD142, 23BBQ558, 23GBC822, 23GBT620, 23JBL757; 24) REF DYNJ67194B, UDI/DI 10195327299699 (each) 40195327299690 (case), Lot Numbers: 23ABQ738; 25) REF DYNJ67210A, UDI/DI 10195327150532 (each) 40195327150533 (case), Lot Numbers: 22GBY195, 22GBO568; 26) REF DYNJ82216, UDI/DI 10195327183769 (each) 40195327183760 (case), Lot Numbers: 23HMI516; 27) REF DYNJ82216B, UDI/DI 10195327534820 (each) 40195327534821 (case), Lot Numbers: 23JMG567; 28) REF DYNJ900091F, UDI/DI 10195327075613 (each) 40195327075614 (case), Lot Numbers: 23ABM839, 23HBA598, 23JBR356, 23HBV298, 23IBP601; 29) REF DYNJ900292K, UDI/DI 10193489915730 (each) 40193489915731 (case), Lot Numbers: 22GBK158, 22FBL459, 23DBA365, 22LBH130, 22LBC401, 23EBT068; 30) REF DYNJ900296J, UDI/DI 10193489915754 (each) 40193489915755 (case), Lot Numbers: 22GBT650, 23DBA294, 23EBG706; 31) REF DYNJ900298J, UDI/DI 10193489915167 (each) 40193489915168 (case), Lot Numbers: 22EBB287, 22DBT480, 23DBD352, 22LBC402, 22KBW389; 32) REF DYNJ900298K, UDI/DI 10195327373337 (each) 40195327373338 (case), Lot Numbers: 23GBM311; 33) REF DYNJ900721C, UDI/DI 10193489951608 (each) 40193489951609 (case), Lot Numbers: 22EBO945, 22HBE990, 23ABQ354, 22LBE624, 22KBC673, 23EBV945; 34) REF DYNJ901807I, UDI/DI 10195327496166 (each) 40195327496167 (case), Lot Numbers: 23KDB594, 23IDC225, 24CDB873, 24BDB761; 35) REF DYNJ906478F, UDI/DI 10195327202675 (each) 40195327202676 (case), Lot Numbers: 23GDB463, 23IDB304; 36) REF DYNJ907220A, UDI/DI 10195327329648 (each) 40195327329649 (case), Lot Numbers: 23BME638; 37) REF DYNJ908792, UDI/DI 10195327183264 (each) 40195327183265 (case), Lot Numbers: 23CDA683; 38) REF DYNJ908795, UDI/DI 10195327183288 (each) 40195327183289 (case), Lot Numbers: 23DDB794, 23FDB261, 23JDB336; 39) REF DYNJ908795B, UDI/DI 10195327535049 (each) 40195327535040 (case), Lot Numbers: 24AMA320, 24BMK237, 24AMH044; 40) REF DYNJ908796, UDI/DI 10195327183271 (each) 40195327183272 (case), Lot Numbers: 23IDA364, 23EDA172; 41) REF DYNJ908796B, UDI/DI 10195327535056 (each) 40195327535057 (case), Lot Numbers: 23LMF165; 42) REF DYNJ908825, UDI/DI 10195327185121 (each) 40195327185122 (case), Lot Numbers: 23BDA825, 23EDC464; 43) REF DYNJ908826, UDI/DI 10195327185145 (each) 40195327185146 (case), Lot Numbers: 22LDA975; 44) REF DYNJ908837, UDI/DI 10195327185169 (each) 40195327185160 (case), Lot Numbers: 23IDB086, 23JDA593, 23HDB464, 23HDB110

Quantity Affected: 3452 units

Reason for Recall

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

Distribution

US Nationwide distribution.

Type: Voluntary: Firm initiated

Recall Initiated: 2024-10-09

Company

MEDLINE INDUSTRIES, LP - Northfield

Northfield, IL

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 225 device recalls issued in the same week, part of 413 device-related FDA actions this month.

MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MEDLINE INDUSTRIES, LP - Northfield) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does MEDLINE INDUSTRIES, LP - Northfield have FDA actions?

MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-0646-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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