|
Class 2 Device Recall Medline CISION Sterile Blades |
|
Date Initiated by Firm |
November 18, 2022 |
Date Posted |
January 11, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0930-2023 |
Recall Event ID |
91317 |
Product Classification |
Blade, saw, general & plastic surgery, surgical - Product Code GFA
|
Product |
Medline CISION Sterile Blades. Labeled as follows with corresponding Item Number.
a. STERILE BLADE NO. 10 CARBON STEEL, Item Number: CISION10CS;
b. STERILE BLADE NO. 10 CARBON STEEL RIB, Item Number: CISION10CSR;
c. STERILE BLADE NO. 11 CARBON STEEL, Item Number: CISION11CS;
d. STERILE BLADE NO. 11 STAINLESS STEEL, Item Number: CISION11SS;
e. STERILE BLADE NO. 11 CARBON STEEL RIB, Item Number: CISION11CSR;
f. STERILE BLADE NO. 15 STAINLESS STEEL, Item Number: CISION15SS;
g. STERILE BLADE NO. 15 CARBON STEEL, Item Number: CISION15CS;
h. STERILE BLADE NO. 15 CARBON STEEL RIB, Item Number: CISION15CSR;
i. STERILE BLADE NO. 20 STAINLESS STEEL, Item Number: CISION20SS;
j. STERILE BLADE NO. 22 CARBON STEEL, Item Number: CISION22CS;
k. STERILE BLADE NO. 22 STAINLESS STEEL, Item Number: CISION22SS.
***Expansion on 02/06/2023 with the following additional products:
l. STERILE BLADE NO. 12 STAINLESS STEEL, Item Number: CISION12SS;
m. STERILE BLADE NO. 20 CARBON STEEL, Item Number: CISION20CS;
n. STERILE BLADE NO. 21 CARBON STEEL, Item Number: CISION21CS;
o. STERILE BLADE NO. 21 STAINLESS STEEL, Item Number: CISION21SS.
Indicated for use in surgical procedures where tissue separation is necessary. |
Code Information |
a. Item Number: CISION10CS, Box UDI/GTIN: 30193489090103, Case UDI/GTIN: 20193489090106, Lot Numbers: Y01853, Z00300, Z02246, Z02288, Z02290, Z02416, Z02246, Z02473, Z02290, Z02290, Z02290, Z02290;
b. Item Number: CISION10CSR, Box UDI/GTIN: 30193489090110, Case UDI/GTIN: 20193489090113, Lot Numbers: Z02259, Z02436, Z00381, Z02202, Z02563, Z02261, Z02435;
c. Item Number: CISION11CS, Box UDI/GTIN: 30193489090134, Case UDI/GTIN: 20193489090137, Lot Numbers: Y03382, Z02183, Z02183, Z02183, Z02470, Z02455, Z02183, Z02455, Z02455, Z02455, Z02470;
d. Item Number: CISION11SS, Box UDI/GTIN: 30193489090158, Case UDI/GTIN: 20193489090151, Lot Numbers: Z02339, Z02339, Z02320, Z02364, Z02364, Z02584, Z00402, Z02584, Z02584;
e. Item Number: CISION11CSR, Box UDI/GTIN: 30193489090141, Case UDI/GTIN: 20193489090144, Lot Number: Z01076;
f. Item Number: CISION15SS, Box UDI/GTIN: 30193489090202, Case UDI/GTIN: 20193489090205, Lot Numbers: Y01861, Z00320, Z02233, Z02492, Z02409, Z02409, Z02409, Z02409, Z02409, Z02482, Z00331, Z02233, Z02377, Z02377, Z02377, Z02377, Z02409, Z02409, Z02409, Z02482;
g. Item Number: CISION15CS, Box UDI/GTIN: 30193489090189, Case UDI/GTIN: 20193489090182, Lot Numbers: Y01848, Y03404, Z02188, Z02611, Z02611, Z02188, Z02611, Z02611, Z02611, Z02611, Z02611, Z02611, Z02611, Z02611;
h. Item Number: CISION15CSR, Box UDI/GTIN: 30193489090196, Case UDI/GTIN: 20193489090199, Lot Numbers: Z02346, Z02346, Z02429, Z02454, Z02429, Z00385;
i. Item Number: CISION20SS, Box UDI/GTIN: 30193489090233, Case UDI/GTIN: 20193489090236, Lot Numbers: Z00343, Z02530;
j. Item Number: CISION22CS, Box UDI/GTIN: 30193489090264, Case UDI/GTIN: 20193489090267, Lot Numbers: Z01064, Z02417, Z02417, Z02198;
k. Item Number: CISION22SS, Box UDI/GTIN: 30193489090288, Case UDI/GTIN: 20193489090281, Lot Numbers: Z02355, Z02403, Z01260, Z02195, Z02355, Z02355.
***Expansion on 02/06/2023 with the following additional products:
l. Item Number: CISION12SS, Box UDI/GTIN: 30193489090172, Case UDI/GTIN: 20193489090175, Lot Number: Z01277;
m. Item Number: CISION20CS, Box UDI/GTIN: 30193489090219, Case UDI/GTIN: 20193489090212, Lot Numbers: Z01206, Z02485, Z02550;
n. Item Number: CISION21CS, Box UDI/GTIN: 30193489090240, Case UDI/GTIN: 20193489090243, Lot Numbers: Z01513, Z02263, Z02452, Z02452, Z02658;
o. Item Number: CISION21SS, Box UDI/GTIN: 30193489090257, Case UDI/GTIN: 20193489090250, Lot Number: Z00312.
|
Recalling Firm/ Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield 3 Lakes Dr Northfield IL 60093-2753
|
For Additional Information Contact |
Karin Johnson 866-359-1704
|
Manufacturer Reason for Recall |
Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging.
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Medline notified customers on about 11/18/2022, via letter. Customers were instructed to immediately check stock for the affected item number and the affected lot numbers, and to destroy all affected product. Customers were also instructed to notify customers if the product was further distributed and to complete a response form. On 02/06/2023, the recall was expanded to include additional item numbers and consignees were notified. |
Quantity in Commerce |
76,053 units |
Distribution |
US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, MD, MI, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA.
|
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.
|
|
|
|