Z-2712-2024Class II
Medline medical procedure kits labeled as follows: a) GYN CDS, REF DYNJ905499B; b) GYN LAP, REF DYNJ909936...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-03-22 / Open, Classified
MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline medical procedure kits labeled as follows: a) GYN CDS, REF DYNJ905499B; b) GYN LAP, REF DYNJ909936; c) GYN LAPAROSCOPY, REF DYNJ902371J; d) GYN... on . FDA classified it as Class II and gives the reason as "A slight dimensional variation which has the potential for increased difficulty fitting into outer canister". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-2712-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline medical procedure kits labeled as follows: a) GYN CDS, REF DYNJ905499B; b) GYN LAP, REF DYNJ909936; c) GYN LAPAROSCOPY, REF DYNJ902371J; d) GYN LAPAROSCOPY, REF DYNJ905509F; e) GYN LAPAROSCOPY II, REF DYNJS2030F; f) LAP ROBOTIC, REF DYNJ902384K; g) LAPAROSCOPY-ROBOT, REF DYNJ905003C; h) ROBOTIC, REF DYNJ907156A
- Product code
- OHD Gynecological Laparoscopic Kit
- Reason for recall
- A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- FDA root cause
- 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
- 964 units
- Distribution
- Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.
- Product codes and lots
- a) REF DYNJ905499B, UDI/DI 40195327316915 (case), 10195327316914 (unit), Lot Numbers: DYNJ905499B, DYNJ905499B, DYNJ905499B, DYNJ905499B; b) REF DYNJ909936, UDI/DI 40195327511204 (case), 10195327511203 (unit), Lot Numbers: 23JBI037, 23KBP829; c) REF DYNJ902371J, UDI/DI 40195327505821 (case), 10195327505820 (unit), Lot Numbers: 23JBU910, 23LBM411; d) REF DYNJ905509F, UDI/DI 40195327269082 (case), 10195327269081 (unit), Lot Numbers: 22LMF016, 23CMH468, 23FMC902; e) REF DYNJS2030F, UDI/DI 40195327386499 (case), 10195327386498 (unit), Lot Numbers: 23EDB982, 23HDA434, 23JDA055; f) REF DYNJ902384K, UDI/DI 40195327503988 (case), 10195327503987 (unit), Lot Numbers: 23KBR180; g) REF DYNJ905003C, UDI/DI 40195327316922 (case), 10195327316921 (unit), Lot Numbers: 23BBP719, 23BBR580, 23DBM969, 23EBT058, 23FBS331, 23GBS886, 23HBP436, 23JBB060, 23LBF305, 23LBP294; h) REF DYNJ907156A, UDI/DI 40193489970266 (case), 10193489970265 (unit), Lot Numbers: 22EME051, 22FMF571, 22GME222, 22KMF942, 22KMF944, 23AMG688, 23BMF088, 23IME181, 23KMF153
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2694-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2695-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2696-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2697-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2698-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2699-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2700-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2701-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2702-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2703-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2704-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2705-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2706-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2707-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2708-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2709-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2710-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2711-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2712-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2713-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2714-2024 | Class II | Ongoing | Voluntary: Firm initiated |
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