| | Class 2 Device Recall Sterile Procedural Trays |  |
| Date Initiated by Firm | November 17, 2022 |
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| Date Posted | February 06, 2023 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1097-2023 |
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| Recall Event ID |
91386 |
| Product Classification |
Arthrogram tray - Product Code OII
|
| Product | Sterile Procedural Trays, labeled as the following:
a. KNEE ARTHROSCOPY CDS-LF
b. ARTHROSCOPY CDS
c. ARTHROSCOPY LV - EDOC PACK-LF
d. ARTHROSCOPY PACK-LF
e. ARTHROSCOPY PACK
f. ARTHRO PACK-LF
g. ARTHROSCOPY PACK-LF
h. ARTHROSCOPY PACK-LF
i. ARTHROSCOPY KNEE TRAY-LF
j. ARTHROSCOPY PACK-LF
k. ARTHROSCOPY BASIN PACK-LF
l. ARTHROTOMY PACK-LF
m. ARTHROSCOPY PACK-LF
n. ARTHROSCOPY PACK
o. ARTHROSCOPY PACK
p. ARTHROSCOPY PACK
q. ARTHROSCOPY PACK - LF
r. SC ARTHROSCOPY PACK
s. ARTHROSCOPY PACK-LF
t. ARTHROSCOPY PACK
u. ARTHROSCOPY PACK
v. ARTHROSCOPY PACK
w. OSC ARTHROSCOPY PK-LF
x. ARTHROSCOPY PACK
y. ARTHROSCOPY PACK
z. ARTHROSCOPY PACK
aa. ARTHROSCOPY PACK
bb. ARTHROSCOPY PACK
cc. KNEE ARTHROSCOPY PACK
dd. KNEE ARTHROSCOPY PACK
ee. SHOULDER ARTHROSCOPY PACK
ff. SHOULDER ARTHROSCOPY
gg. ARTHROSCOPY PACK
hh. ARTHROSCOPY PACK
ii. ARTHROSCOPY PACK
jj. ARTHROSCOPY PACK
kk. ARTHROSCOPY PACK
ll. ARTHROSCOPY PACK-LF
mm. ARTHROSCOPY KNEE
nn. ARTHROSCOPY PACK
oo. HIP ARTHROSCOPY PACK
pp. ARTHROSCOPY PACK
qq. MG NS KNEE ARTHROSCOPY PACK
rr. KNEE ARTHROSCOPY PACK
ss. ARTHROSCOPY PACK
tt. ARTHROSCOPY-LF
uu. ARTHROSCOPY KIT
vv. SHOULDER ARTHROSCOPY
ww. KNEE ARTHROSCOPY
xx. ARTHROSCOPY PACK |
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| Code Information |
a. KNEE ARTHROSCOPY CDS-LF, Item Number: CDS940869U, Case UDI/GTIN: 40195327210046, Unit UDI/GTIN: 10195327210045, Lot Number: 22JBR468,22JBA443;
b. ARTHROSCOPY CDS, Item Number: CDS985208B, Case UDI/GTIN: 40889942942061, Unit UDI/GTIN: 10889942942060, Lot Number: 22JBR379,22IBS410,22IBO331,22IBO332;
c. ARTHROSCOPY LV - EDOC PACK-LF, Item Number: DYNJ0111409L, Case UDI/GTIN: 40889942824015, Unit UDI/GTIN: 10889942824014, Lot Number: 22JMH535,22IMF440;
d. ARTHROSCOPY PACK-LF, Item Number: DYNJ0376528J, Case UDI/GTIN: 40889942395935, Unit UDI/GTIN: 10889942395934, Lot Number: 22JBJ567;
e. ARTHROSCOPY PACK, Item Number: DYNJ04446N, Case UDI/GTIN: 40888277753649, Unit UDI/GTIN: 10888277753648, Lot Number: 22JMH875,22HMG756;
f. ARTHRO PACK-LF, Item Number: DYNJ0637509B, Case UDI/GTIN: 40889942079255, Unit UDI/GTIN: 10889942079254, Lot Number: 22IMH393;
g. ARTHROSCOPY PACK-LF, Item Number: DYNJ0751097M, Case UDI/GTIN: 40195327196364, Unit UDI/GTIN: 10195327196363, Lot Number: 22HMC138;
h. ARTHROSCOPY PACK-LF, Item Number: DYNJ0890114F, Case UDI/GTIN: 40889942824039, Unit UDI/GTIN: 10889942824038, Lot Number: 22JMC992,22IMG334;
i. ARTHROSCOPY KNEE TRAY-LF, Item Number: DYNJ09577J, Case UDI/GTIN: 40889942104803, Unit UDI/GTIN: 10889942104802, Lot Number: 22IBJ738;
j. ARTHROSCOPY PACK-LF, Item Number: DYNJ15916C, Case UDI/GTIN: 40888277861610, Unit UDI/GTIN: 10888277861619, Lot Number: 22KBA679,22JBS955;
k. ARTHROSCOPY BASIN PACK-LF, Item Number: DYNJ16633C, Case UDI/GTIN: 40888277858450, Unit UDI/GTIN: 10888277858459, Lot Number: 22JBV974;
l. ARTHROTOMY PACK-LF, Item Number: DYNJ19751B, Case UDI/GTIN: 40884389018423, Unit UDI/GTIN: 10884389018422, Lot Number: 22IME726;
m. ARTHROSCOPY PACK-LF, Item Number: DYNJ24861D, Case UDI/GTIN: 40888277545398, Unit UDI/GTIN: 10888277545397, Lot Number: 22JBJ980,22JBG368;
n. ARTHROSCOPY PACK, Item Number: DYNJ26870I, Case UDI/GTIN: 40889942605669, Unit UDI/GTIN: 10889942605668, Lot Number: 22IBN707;
o. ARTHROSCOPY PACK, Item Number: DYNJ30719C, Case UDI/GTIN: 40888277077745, Unit UDI/GTIN: 10888277077744, Lot Number: 22JBW329;
p. ARTHROSCOPY PACK, Item Number: DYNJ31889C, Case UDI/GTIN: 40889942122777, Unit UDI/GTIN: 10889942122776, Lot Number: 22JBF800;
q. ARTHROSCOPY PACK - LF, Item Number: DYNJ33193A, Case UDI/GTIN: 40884389363967, Unit UDI/GTIN: 10884389363966, Lot Number: 22IBD173;
r. SC ARTHROSCOPY PACK, Item Number: DYNJ34330C, Case UDI/GTIN: 40889942577027, Unit UDI/GTIN: 10889942577026, Lot Number: 22IMD384;
s. ARTHROSCOPY PACK-LF, Item Number: DYNJ34797I, Case UDI/GTIN: 40889942451693, Unit UDI/GTIN: 10889942451692, Lot Number: 22IMC421;
t. ARTHROSCOPY PACK, Item Number: DYNJ35435C, Case UDI/GTIN: 40888277554697, Unit UDI/GTIN: 10888277554696, Lot Number: 22JBF703;
u. ARTHROSCOPY PACK, Item Number: DYNJ35733F, Case UDI/GTIN: 40889942107866, Unit UDI/GTIN: 10889942107865, Lot Number: 22IBN489;
v. ARTHROSCOPY PACK, Item Number: DYNJ36624D, Case UDI/GTIN: 40889942540304, Unit UDI/GTIN: 10889942540303, Lot Number: 22JBG374,22IBA906;
w. OSC ARTHROSCOPY PK-LF, Item Number: DYNJ37381C, Case UDI/GTIN: 40889942292210, Unit UDI/GTIN: 10889942292219, Lot Number: 22JBY499,22JBB033,22HBY104;
x. ARTHROSCOPY PACK, Item Number: DYNJ40334, Case UDI/GTIN: 40884389852737, Unit UDI/GTIN: 10884389852736, Lot Number: 22JBK330;
y. ARTHROSCOPY PACK, Item Number: DYNJ42208B, Case UDI/GTIN: 40888277744142, Unit UDI/GTIN: 10888277744141, Lot Number: 22JBP189;
z. ARTHROSCOPY PACK, Item Number: DYNJ45173D, Case UDI/GTIN: 40889942485223, Unit UDI/GTIN: 10889942485222, Lot Number: 22JBG783;
aa. ARTHROSCOPY PACK, Item Number: DYNJ45340B, Case UDI/GTIN: 40889942120605, Unit UDI/GTIN: 10889942120604, Lot Number: 22IBL202;
bb. ARTHROSCOPY PACK, Item Number: DYNJ47103C, Case UDI/GTIN: 40889942489177, Unit UDI/GTIN: 10889942489176, Lot Number: 22JMH577,22IME064;
cc. KNEE ARTHROSCOPY PACK, Item Number: DYNJ48572, Case UDI/GTIN: 40888277913890, Unit UDI/GTIN: 10888277913899, Lot Number: 22JBH940;
dd. KNEE ARTHROSCOPY PACK, Item Number: DYNJ50120D, Case UDI/GTIN: 40195327195657, Unit UDI/GTIN: 10195327195656, Lot Number: 22JBG571;
ee. SHOULDER ARTHROSCOPY PACK, Item Number: DYNJ50126D, Case UDI/GTIN: 40195327212170, Unit UDI/GTIN: 10195327212179, Lot Number: 22JBG572,22IBD245;
ff. SHOULDER ARTHROSCOPY, Item Number: DYNJ51381, Case UDI/GTIN: 40889942161325, Unit UDI/GTIN: 10889942161324, Lot Number: 22JBG797;
gg. ARTHROSCOPY PACK, Item Number: DYNJ52778A, Case UDI/GTIN: 40889942638117, Unit UDI/GTIN: 10889942638116, Lot Number: 22HMC946;
hh. ARTHROSCOPY PACK, Item Number: DYNJ52813, Case UDI/GTIN: 40889942328926, Unit UDI/GTIN: 10889942328925, Lot Number: 22JBD518;
ii. ARTHROSCOPY PACK, Item Number: DYNJ56088A, Case UDI/GTIN: 40888277762900, Unit UDI/GTIN: 10888277762909, Lot Number: 22JBW279,22HBR114;
jj. ARTHROSCOPY PACK, Item Number: DYNJ57151, Case UDI/GTIN: 40889942721901, Unit UDI/GTIN: 10889942721900, Lot Number: 22JBI446;
kk. ARTHROSCOPY PACK, Item Number: DYNJ57741, Case UDI/GTIN: 40889942773672, Unit UDI/GTIN: 10889942773671, Lot Number: 22JBD988;
ll. ARTHROSCOPY PACK-LF, Item Number: DYNJ58470, Case UDI/GTIN: 40889942856030, Unit UDI/GTIN: 10889942856039, Lot Number: 22JBT149,22IBU283;
mm. ARTHROSCOPY KNEE, Item Number: DYNJ68081B, Case UDI/GTIN: 40195327199853, Unit UDI/GTIN: 10195327199852, Lot Number: 22IBN483;
nn. ARTHROSCOPY PACK, Item Number: DYNJ82486, Case UDI/GTIN: 40195327197422, Unit UDI/GTIN: 10195327197421, Lot Number: 22HBT060;
oo. HIP ARTHROSCOPY PACK, Item Number: DYNJ82503, Case UDI/GTIN: 40195327197378, Unit UDI/GTIN: 10195327197377, Lot Number: 22HBL505;
pp. ARTHROSCOPY PACK, Item Number: DYNJ82546, Case UDI/GTIN: 40195327197927, Unit UDI/GTIN: 10195327197926, Lot Number: 22HBV066;
qq. MG NS KNEE ARTHROSCOPY PACK, Item Number: DYNJ82585, Case UDI/GTIN: 40195327198764, Unit UDI/GTIN: 10195327198763, Lot Number: 22IBE887;
rr. KNEE ARTHROSCOPY PACK, Item Number: DYNJ82630, Case UDI/GTIN: 40195327199525, Unit UDI/GTIN: 10195327199524, Lot Number: 22JBE442;
ss. ARTHROSCOPY PACK, Item Number: DYNJ82707, Case UDI/GTIN: 40195327202317, Unit UDI/GTIN: 10195327202316, Lot Number: 22JMH335,22JMF855;
tt. ARTHROSCOPY-LF, Item Number: DYNJ903247B, Case UDI/GTIN: 40889942754664, Unit UDI/GTIN: 10889942754663, Lot Number: 22JBQ059;
uu. ARTHROSCOPY KIT, Item Number: DYNJ904304G, Case UDI/GTIN: 40195327209316, Unit UDI/GTIN: 10195327209315, Lot Number: 22JBR652,22IBT829;
vv. SHOULDER ARTHROSCOPY, Item Number: DYNJ908907, Case UDI/GTIN: 40195327215577, Unit UDI/GTIN: 10195327215576, Lot Number: 22JBJ375;
ww. KNEE ARTHROSCOPY, Item Number: DYNJ908920, Case UDI/GTIN: 40195327215874, Unit UDI/GTIN: 10195327215873, Lot Number: 22JBA830;
xx. ARTHROSCOPY PACK, Item Number: DYNJHS0101I, Case UDI/GTIN: 40888277046413, Unit UDI/GTIN: 10888277046412, Lot Number: 22IBK139 |
Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
|
| For Additional Information Contact | Karin Johnson
886-359-1704 |
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Manufacturer Reason
for Recall | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
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FDA Determined
Cause 2 | Device Design |
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| Action | Medline Industries, LP notified consignees via email and first-class mail on 11/15/2022. Consignees were instructed to check stock for affected product and immediately quarantine. For any affected units, customers were instructed to over-label the sterile kits with a warning label indicating "Warning To Avoid Injury, Please Handle Blades with Care." No product is to be returned. Customers were also instructed to complete and return the response form and notify customers if further distributed. |
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| Quantity in Commerce | 1,419 cases (4,349 units) |
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| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates. |
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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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