Device recalls

CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile, Hypoallergenic.

Cardinal Health 200, LLC · Potential contamination of the product with latex adhesive residual.

Open, ClassifiedUnder Investigation by firmZ-1835-2024
Open FDA's page for this record
Cfres ID
207175
Product res number
Z-1835-2024
Event date initiated
2024-04-17
Event date posted
2024-05-16
Recall status
Open, Classified
Res event number
94407
Product code
KGX
Product description
CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile, Hypoallergenic.
Code info
Lot #A14722, UDI-DI: 50192253049907 (CS), 20192253049906 (BX)
Firm FEI number
3001236905
Recalling firm
Cardinal Health 200, LLC
Address 1
3651 Birchwood Dr
City
Waukegan
State
IL
Postal code
60085-8337
Additional info contact
847-887-5500
Reason for recall
Potential contamination of the product with latex adhesive residual.
Root cause description
Under Investigation by firm
Product quantity
2,000 packages
Distribution pattern
US Nationwide distribution.
Action

On 4/17/2024, the recalling firm issued letters dated 4/17/2024 via overnight mail explaining the reason for recall, the risk to health, and the required actions, which were: (1) Review inventory for the affected product code and lot number; (2) communicate with all personnel that utilize the product; (3) segregate and quarantine all affected product and utilize the return directions in the letter; (4) disseminate the notice to all departments, clinics, and external campuses that handle the affected product; (5) distributors are to notify any customers to whom they may have distributed/forwarded the affected product to or plan to send the product; (6) return the enclosed acknowledgment form via FAX or email whether or not the consignee has the product. The letter contained the various phone numbers for the Customer Service groups (hospital, federal government, distributor, and all other customers) to arrange for return of the product and for questions related to the recall. An attachment was enclosed with the letter to show an example of where the lot number can be located on the label.

Harmonized identifiers (openFDA)
Device name
Tape And Bandage, Adhesive
Medical specialty description
General Hospital
Regulation number
880.5240
Device class
1
K number
K841897, K896733, K813361, K802764, K923319, K883660, K802242, K941788, K840609, K811291, K935948, K843873, K923300, K894274, K870900, K944588, K912160, K853647, K884108, K802795, K905022, K870093, K895920, K872593, K942383, K842946, K930457, K912550, K840951, K921759, K792102, K926264, K810053, K880964, K810050, K941379, K912623, K791885, K925384, K932602 +147 more
Registration number
3017231740, 3006554788, 3005630901, 1030451, 3004111573, 3042277868, 3045076483, 2214133, 3032911850, 8044116, 3004950768, 3031743608, 3023809973, 3011191255, 3024088964, 3010398913, 3009349165, 3016872092, 3008174904, 3013525506, 3016159364, 3017448136, 3017672584, 3014368824, 1226711, 3013473968, 2135339, 1836161, 3031841433, 3007048057, 3043740372, 3010380518, 1450662, 3025440611, 3005024024, 9611024, 3006260740, 9680271, 3014656668, 3005941719 +965 more
FEI number
3003338236, 3017231740, 3006554788, 3005630901, 1030451, 3004111573, 3042277868, 3045076483, 3002807038, 2214133, 3032911850, 1000220650, 3004950768, 3031743608, 3023809973, 3011191255, 3024088964, 3003753482, 3010398913, 3009349165, 3016872092, 3008174904, 3013525506, 3016159364, 3017448136, 3017672584, 3003191258, 3030824101, 1000306431, 3014368824, 3013473968, 3004574120, 1000112877, 1000123297, 3031841433, 3007048057, 3011774813, 3043740372, 3041329419, 3006076154 +965 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.