| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | October 09, 2024 |
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| Date Posted | December 05, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0646-2025 |
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| Recall Event ID |
95621 |
| Product Classification |
Hysterectomy kit - Product Code OJF
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| Product | 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 |
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| Code Information |
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
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Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
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| For Additional Information Contact | Haley Barclay
866-359-1704 |
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Manufacturer Reason
for Recall | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | Medline issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 10/11/2024 via mail and email. The notice explained the problem with the Stryker component, potential risk, requested the kits be quarantined pending additional labeling and o respond through their portal: https://recalls.medline.com. Once the response is received, Medline will provide additional labeling to be applied to the affected kits which states the following: "Attention: R-24-219, This kit contains a recalled item, STRYKER SafeAir Smoke Evacuation Pencil, VPN: 0703-047-000, 0703-047-001, 0703-047-002, 0703-046-000, 0703-046-001, 0703-046-002. DO NOT USE THIS COMPONENT. The rest of the kit may be used. Please remove this item only and replace with product from supply. *Do not cover or remove this sticker*".
Those further distributing the product were directed to notify their customers.
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| Quantity in Commerce | 3452 units |
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| Distribution | US Nationwide distribution. |
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| Total Product Life Cycle | TPLC Device Report |
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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