| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | March 22, 2024 |
|---|
| Date Posted | August 22, 2024 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2703-2024 |
|---|
| Recall Event ID |
94356 |
| Product Classification |
Ear, nose, and throat surgical tray - Product Code OGR
|
| Product | Medline medical procedure kits labeled as follows:
a) BASIC NASAL, REF DYNJ909932;
b) BRONCH KIT, REF DYKE1007B;
c) ENT, REF DYNJ909935;
d) NASAL SINUS-LF, REF DYNJ902624G;
e) ORAL, REF DYNJ902377I;
f) PACK,BRONCHOSCOPY, REF DYNJ65475B;
g) PACK,HEAD AND NECK, REF DYNJ65487B;
h) PACK,SINUS, REF DYNJ906898;
i) PACK,T & A, REF DYNJ906897B;
j) PACK,T & A ASC, REF DYNJ906914;
k) T AND A, REF DYNJ909941 |
|---|
| Code Information |
a) REF DYNJ909932, UDI/DI 40195327511167 (case), 10195327511166 (unit), Lot Numbers: 23JBI290, 23KBI103;
b) REF DYKE1007B, UDI/DI 40195327203697 (case), 10195327203696 (unit), Lot Numbers: 22HBF709, 22HBV977, 22LBC080, 22LBH793, 23CBP363, 23DBL601, 23EBT148, 23FBS311, 23GBP583, 23HBY932, 23JBK265,;
c) REF DYNJ909935, UDI/DI 40195327511198 (case), 10195327511197 (unit), Lot Numbers: 23JBH869;
d) REF DYNJ902624G, UDI/DI 40195327214525 (case), 10195327214524 (unit), Lot Numbers: 22IBA877, 22IBN753, 23DBG397, 23FBN458, 23GBG939, 23HBT691, 23JBQ259, 23KBO185;
e) REF DYNJ902377I, UDI/DI 40195327505883 (case), 10195327505882 (unit), Lot Numbers: 23JBI663;
f) REF DYNJ65475B, UDI/DI 40195327303519 (case), 10195327303518 (unit), Lot Numbers: 22LBE939, 23ABK037, 23BBI110, 23CBH860, 23DBF474, 23DBS953, 23GBN857, 23JBE718, 23KBL576;
g) REF DYNJ65487B, UDI/DI 40195327303663 (case), 10195327303662 (unit), Lot Numbers: 22LBP408, 23ABN443, 23CBM523, 23DBM713, 23IBM894;
h) REF DYNJ906898, UDI/DI 40193489281928 (case), 10193489281927 (unit), Lot Numbers: 22HBA414, 22JBR764, 23FBK308, 23GBC593, 23IBF940, 23KBO165, 23KBT057;
i) REF DYNJ906897B, UDI/DI 40195327373147 (case), 10195327373146 (unit), Lot Numbers: 23EBE963, 23EBL760, 23FBC942, 23FBC943, 23HBQ553, 23HBS215, 23IBD903, 23KBE192, 23KBI100, 23LBH012;
j) REF DYNJ906914, UDI/DI 40193489280174 (case), 10193489280173 (unit), Lot Numbers: 22EBS455, 22EBU139, 22GBK146, 22HBG371, 22JBG419, 22KBI283, 23ABC387, 23CBI473, 23CBO589, 23CBU019, 23EBE957, 23EBV972, 23GBB581, 23IBP952, 23IBV288, 23JBB697, 23LBJ608;
k) REF DYNJ909941, UDI/DI 40195327511006 (case), 10195327511005 (unit), Lot Numbers: 23JBH984
|
Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
|
| For Additional Information Contact | Karin Johnson
886-359-1704 |
|---|
Manufacturer Reason
for Recall | A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
|---|
| Action | Medline Industries issued a Safety Alert to its consignees on 03/22/2024 via email and certified mail. The notice explained the problem with the device and requested that consignees follow the instructions for use. Distributors or those who further transferred the affected product were directed to notify their consignees. |
|---|
| Quantity in Commerce | 6998 units |
|---|
| Distribution | Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.
|
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
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.
|
|
|
|
