| | Class 2 Device Recall ECONO STERILE |  |
| Date Initiated by Firm | December 03, 2024 |
|---|
| Date Posted | January 16, 2025 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0939-2025 |
|---|
| Recall Event ID |
95946 |
| 510(K)Number | K772229 K801273 |
|---|
| Product Classification |
Forceps, general & plastic surgery - Product Code GEN
|
| Product | ECONO STERILE medical procedure kits labeled as:
1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,Model Number 94-0286;
2) ECONO STERILE DRESSING FCP 5.5" CS/25LG,Model Number 94-0290;
3) ECONO STERILE TISSUE FCP 1X2 5.5" STER CS25,Model Number 94-0291;
4) ECONO STERILE FRCPS JANSEN BAYO STRL6.25 C25,Model Number 941-0691;
5) ECONO STERILE IRIS FCP SERR 4.25 STER CS100,Model Number 941-1414;
6) ECONO STERILE PEDIATRIC MAGILL CATH FCP CS25,Model Number 94-1924;
7) ECONO STERILE STRL ALLIGATOR FCPS 3.5" 25/CS,Model Number 94-5034;
8) ECONO STERILE SERR DRESSING FCP 5 1/2" CS/50,Model Number 94-6146;
9) ECONO STERILE KELLY RANKIN FCP CVD 6.25 CS25,Model Number 94-6616;
10) ECONO STERILE JANSEN NSL FCP BY6.5 STRLCS/25,Model Number 96-2215A;
11) ECONO STERILE BALLENGR SPNG FCP SERR7"CS/25,Model Number 96-2289;
12) ECONO STERILE LUCAE BAYONET FCP SERR5.5CS/25,Model Number 96-2293;
13) ECONO STERILE LUCAE BAYONET FCP SERR5.5CS/25,Model Number 96-2293A;
14) ECONO STERILE RUSSIAN TISSUE FCP 6" STER25,Model Number 96-2295A;
15) ECONO STERILE TISSUE FCP 1X2 8" STRL CS/25,Model Number 96-2351;
16) ECONO STERILE SCHROEDER BRAUN TEN FCP10CS/25,Model Number 96-2386;
17) ECONO STERILE TUBE OCCL FCP SM STR 7"STER 50,Model Number 96-2406;
18) ECONO STERILE TUBE OCC FCP SM STR 7" STER 25,Model Number 96-2408;
19) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 50,Model Number 96-2410;
20) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412;
21) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412A;
22) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412M;
23) ECONO STERILE SEMKEN DRESS FCP SERR 5"STER25,Model Number 96-2450M;
24) ECONO STERILE RANKIN KELLY FCP STR6.25 CS/25,Model Number 96-2461;
25) ECONO STERILE RANKIN KELLY FCP CVD6.25 CS/25,Model Number 96-2462;
26) ECONO STERILE IRIS FCP X-FINE ANG 3.5 STER25,Model Number 96-2470A;
27) ECONO STERILE IRIS FCP X-FINE STR 3.5 STER25,Model Number 96-2472A;
28) ECONO STERILE IRIS FCP 1/2CVD SERR STER CS25,Model Number 96-2515;
29) ECONO STERILE IRIS FCP 1/2CVD 1x2 STER CS25,Model Number 96-2515A;
30) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER50,Model Number 96-2532;
31) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER25,Model Number 96-2533;
32) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER25,Model Number 96-2533A;
33) ECONO STERILE SPONGE FCP STR SERR 9.5 STER25,Model Number 96-2533M;
34) ECONO STERILE FOERSTER SPG FCP CVD 9.5STER25,Model Number 96-2534;
35) ECONO STERILE FOERSTER SPG FCP CVD 9.5STER25,Model Number 96-2534A;
36) ECONO STERILE IRIS FCP STR 1X2 4" STER CS/25,Model Number 96-2535A;
37) ECONO STERILE HALSTED FCP STR 5" STER CS/50,Model Number 96-2536;
38) ECONO STERILE HALSTED FCP STR 5" STER CS/50,Model Number 96-2536M;
39) ECONO STERILE HALSTED FCP STR 5" STER CS/25,Model Number 96-2537;
40) ECONO STERILE HALSTED FCP STR 5" STER CS/25,Model Number 96-2537A;
41) ECONO STERILE HALSTED FCP STR 5" STER CS/25,Model Number 96-2537M;
42) ECONO STERILE HALSTED FCP CVD 5" STER CS/50,Model Number 96-2538;
43) ECONO STERILE HALSTED FCP CVD 5" STER CS/25,Model Number 96-2539;
44) ECONO STERILE HALSTED FCP CVD 5" STER CS/25,Model Number 96-2539A;
45) ECONO STERILE HALSTED FCP CVD 5" STER CS/25,Model Number 96-2539M;
46) ECONO STERILE ROCH PEAN FCP STR STER 61/4 50,Model Number 96-2544;
47) ECONO STERILE ROCH PEAN FCP STR STER 61/4 25,Model Number 96-2545;
48) ECONO STERILE ROCH PEAN CVD 6 1/4 STERL CS25,Model Number 96-2547;
49) ECONO STERILE ROCH PEAN CVD 6 1/4 STER CS/25,Model Number 96-2547A;
50) ECONO STERILE ROCH-PEAN FCP CVD 8.5" STER 25,Model Number 96-2548;
51) ECONO STERILE ROCH-PEAN FCP CVD 8.5" STER 50,Model Number 96-2549;
52) ECONO STERILE CRILE FCP STR 5.5" STERL CS/50,Model Number 96-2550;
53) ECONO STERILE CRILE FCP STR 5.5" STERL CS/25,Model Number 96-2551;
54) ECONO STERILE CRILE FCP STR 5.5" STERL CS/25,Model Number 96-2551A; |
|---|
| Code Information |
1) 94-0286, UDI/DI 50649111094406, Lot codes: FSF21;
2) 94-0290, UDI/DI 50649111095045, Lot codes: SK-115;
3) 94-0291, UDI/DI 50649111095144, Lot codes: 824940291, 924940291;
4) 941-0691, UDI/DI 50649111307902, Lot codes: MST8, MST9;
5) 941-1414, UDI/DI 50649111464872, Lot codes: SK-122;
6) 94-1924, UDI/DI 50649111345775, Lot codes: FSF16, FSF22;
7) 94-5034, UDI/DI 50649111040687, Lot codes: SK-112, SK-135;
8) 94-6146, UDI/DI 50649111215535, Lot codes: SK-135;
9) 94-6616, UDI/DI 50649111287457, Lot codes: SK-132;
10) 96-2215A, UDI/DI 50649111487567, Lot codes: HSI;
11) 96-2289, UDI/DI 50649111439986, Lot codes: SK-116;
12) 96-2293, UDI/DI 50649111440012, Lot codes: SK-115, SK-132;
13) 96-2293A, UDI/DI 50649111487598, Lot codes: HSI;
14) 96-2295A, UDI/DI 50649111493254, Lot codes: HST21;
15) 96-2351, UDI/DI 50649111440081, Lot codes: FST21;
16) 96-2386, UDI/DI 50649111440241, Lot codes: FSF18;
17) 96-2406, UDI/DI 50649111035195, Lot codes: FSF18, FSF24, FSF25;
18) 96-2408, UDI/DI 50649111035355, Lot codes: FSF5, FSF12, FSF18, FSF26;
19) 96-2410, UDI/DI 50649111035669, Lot codes: FST9;
20) 96-2412, UDI/DI 50649111035867, Lot codes: FST6, FST9, FST10, FST11, FST12, FST20;
21) 96-2412A, UDI/DI 50649111487550, Lot codes: SK-112;
22) 96-2412M, UDI/DI 50649111027015, Lot codes: 0724962412M;
23) 96-2450M, UDI/DI 50649111464483, Lot codes: 0624962450M;
24) 96-2461, UDI/DI 50649111440432, Lot codes: SK-132;
25) 96-2462, UDI/DI 50649111464490, Lot codes: SK-132;
26) 96-2470A, UDI/DI 50649111487970, Lot codes: SK-112;
27) 96-2472A, UDI/DI 50649111487987, Lot codes: SK-112;
28) 96-2515, UDI/DI 50649111050235, Lot codes: SK-115;
29) 96-2515A, UDI/DI 50649111487857, Lot codes: SK-112;
30) 96-2532, UDI/DI 50649111053212, Lot codes: FSF8, FSF14;
31) 96-2533, UDI/DI 50649111053397, Lot codes: FSF8, FSF11, FSF14, FSF16, FSF17, FSF20, FSF21, FSF22, FSF23;
32) 96-2533A, UDI/DI 50649111487888, Lot codes: HSI;
33) 96-2533M, UDI/DI 50649111215313, Lot codes: SK-116;
34) 96-2534, UDI/DI 50649111478817, Lot codes: FSF15, FSF21, FSF22, FSF23;
35) 96-2534A, UDI/DI 50649111492653, Lot codes: HSF8, HSF18;
36) 96-2535A, UDI/DI 50649111488304, Lot codes: SK-112;
37) 96-2536, UDI/DI 50649111054172, Lot codes: FSF10, FSF21;
38) 96-2536M, UDI/DI 50649111220034, Lot codes: 0724962536M;
39) 96-2537, UDI/DI 50649111054424, Lot codes: FSF5, FSF10;
40) 96-2537A, UDI/DI 50649111219496, Lot codes: SK-112;
41) 96-2537M, UDI/DI 50649111221758, Lot codes: 0724962537M;
42) 96-2538, UDI/DI 50649111054639, Lot codes: FSF10, FSF14, FSF18, FSF20, FSF21, FSF22, FSF23;
43) 96-2539, UDI/DI 50649111054783, Lot codes: FSF5, FSF6, FSF10, FSF12, FSF13, FSF14, FSF18, FSF21, FSF22, FSF24;
44) 96-2539A, UDI/DI 50649111487901, Lot codes: SK-112;
45) 96-2539M, UDI/DI 50649111225336, Lot codes: 0724962539M;
46) 96-2544, UDI/DI 50649111056008, Lot codes: FSF8, FSF10;
47) 96-2545, UDI/DI 50649111056183, Lot codes: FSF10, FSF21;
48) 96-2547, UDI/DI 50649111056497, Lot codes: FSF8, FSF10, FSF13, FSF20, FSF21, FSF22, FSF24, FSF26;
49) 96-2547A, UDI/DI 50649111236417, Lot codes: SK-112, SK-136;
50) 96-2548, UDI/DI 50649111056725, Lot codes: FSF12;
51) 96-2549, UDI/DI 50649111056800, Lot codes: FSF8, FSF17, FSF26;
52) 96-2550, UDI/DI 50649111057135, Lot codes: FSF9, FSF19, FSF22, FSF24;
53) 96-2551, UDI/DI 50649111057234, Lot codes: FSF9, FSF20, FSF24, FSF25;
54) 96-2551A, UDI/DI 50649111487819, Lot codes: SK-112;
55) 96-2552, UDI/DI 50649111057579, Lot codes: FSF13, FSF14, FSF16, FSF21, FSF24;
56) 96-2552M, UDI/DI 50649111400818, Lot codes: SK-133;
57) 96-2553, UDI/DI 50649111057715, Lot codes: FSF5;
58) 96-2554, UDI/DI 50649111057814, Lot codes: SK-134;
59) 96-2555, UDI/DI 50649111057982, Lot codes: FSF19, FSF20, FSF26;
60) 96-2556, UDI/DI 50649111058248, Lot codes: SK-131;
61) 96-2557, UDI/DI 50649111058545, Lot codes: FSF19, FSF26;
62) 96-2558, UDI/DI 50649111058644, Lot codes: SK-131;
63) 96-2559, UDI/DI 50649111058903, Lot codes: SK-115;
64) 96-2559A, UDI/DI 50649111487635, Lot codes: SK-112;
65) 96-2560, UDI/DI 50649111059078, Lot codes: FSF13, FSF14, FSF19, FSF20, FSF21, FSF22, FSF24, FSF25, FSF26;
66) 96-2561, UDI/DI 50649111059290, Lot codes: FSF5, FSF7, FSF8, FSF9, FSF19, FSF20, FSF22, FSF24;
67) 96-2561A, UDI/DI 50649111488007, Lot codes: SK-112;
68) 96-2561M, UDI/DI 50649111259041, Lot codes: 0724962561M;
69) 96-2562, UDI/DI 50649111059511, Lot codes: FSF7, FSF8, FSF11, FSF12, FSF18, FSF19, FSF21, FSF22, FSF26;
70) 96-2563, UDI/DI 50649111059733, Lot codes: FSF5, FSF9, FSF12, FSF14, FSF17, FSF21, FSF22, FSF24;
71) 96-2563A, UDI/DI 50649111487994, Lot codes: SK-112;
72) 96-2563M, UDI/DI 50649111262218, Lot codes: 0724962563M;
73) 96-2566A, UDI/DI 50649111488175, Lot codes: SK-112;
74) 96-2568, UDI/DI 50649111060531, Lot codes: FST13, FST21;
75) 96-2568A, UDI/DI 50649111267558, Lot codes: SK-115;
76) 96-2569, UDI/DI 50649111060715, Lot codes: FST9, FST10, FST21;
77) 96-2569A, UDI/DI 50649111487840, Lot codes: HSI;
78) 96-2570, UDI/DI 50649111060845, Lot codes: SK-115;
79) 96-2570M, UDI/DI 50649111271821, Lot codes: SK-116;
80) 96-2571, UDI/DI 50649111061033, Lot codes: SK-115;
81) 96-2571A, UDI/DI 50649111487642, Lot codes: HSI;
82) 96-2571M, UDI/DI 50649111273498, Lot codes: SK-116;
83) 96-2572, UDI/DI 50649111061187, Lot codes: SK-115;
84) 96-2573, UDI/DI 50649111061408, Lot codes: SK-115, SK-130;
85) 96-2573A, UDI/DI 50649111487758, Lot codes: HSI;
86) 96-2573M, UDI/DI 50649111276697, Lot codes: SK-115, SK-116;
87) 96-2575, UDI/DI 50649111061644, Lot codes: FSF9;
88) 96-2575A, UDI/DI 50649111487789, Lot codes: SK-112;
89) 96-2576, UDI/DI 50649111061897, Lot codes: FSF9;
90) 96-2578, UDI/DI 50649111062375, Lot codes: 724962578;
91) 96-2579, UDI/DI 50649111062542, Lot codes: 724962579;
92) 96-2579M, UDI/DI 50649111285576, Lot codes: 0724962579M;
93) 96-2588, UDI/DI 50649111064096, Lot codes: SK-115;
94) 96-2620, UDI/DI 50649111070493, Lot codes: SK-130;
95) 96-2622, UDI/DI 50649111070851, Lot codes: SK-130, SK-131;
96) 96-2622A, UDI/DI 50649111487802, Lot codes: SK-112;
97) 96-2623A, UDI/DI 50649111488205, Lot codes: SK-112, SK-134;
98) 96-2624, UDI/DI 50649111071209, Lot codes: FSF12, FSF17, FSF18, FSF19, FSF20, FSF22, FSF23, FSF24, FSF25;
99) 96-2624A, UDI/DI 50649111488212, Lot codes: SK-112;
100) 96-2626, UDI/DI 50649111071476, Lot codes: FSF15, FSF22;
101) 96-2653, UDI/DI 50649111076525, Lot codes: FSF8, FSF9, FSF18, FSF20, FSF24;
102) 96-2655, UDI/DI 50649111077027, Lot codes: SK-115;
103) 96-2656, UDI/DI 50649111077072, Lot codes: SK-115;
104) 96-2657, UDI/DI 50649111077232, Lot codes: FSF8, FSF10;
105) 96-2658, UDI/DI 50649111077461, Lot codes: FSF10, FSF17, FSF18, FSF24;
106) 96-2660, UDI/DI 50649111077928, Lot codes: FST10, FST13;
107) 96-2661, UDI/DI 50649111078024, Lot codes: 724962661;
108) 96-2670, UDI/DI 50649111079588, Lot codes: SK-115;
109) 96-2670M, UDI/DI 50649111034556, Lot codes: 0724962670M;
110) 96-2684, UDI/DI 50649111081703, Lot codes: SK-116;
111) 96-2685, UDI/DI 50649111081857, Lot codes: SK-116;
112) 96-2685A, UDI/DI 50649111488038, Lot codes: 60359;
113) 96-2687A, UDI/DI 50649111488311, Lot codes: 60431;
114) 96-2688, UDI/DI 50649111082335, Lot codes: SK-115;
115) 96-2689, UDI/DI 50649111082472, Lot codes: SK-116;
116) 96-2706, UDI/DI 50649111084995, Lot codes: SK-130;
117) 96-2736A, UDI/DI 50649111487918, Lot codes: SK-112;
118) 96-2737A, UDI/DI 50649111488106, Lot codes: SK-112;
119) 96-2738A, UDI/DI 50649111487956, Lot codes: SK-112;
120) 96-2739A, UDI/DI 50649111487963, Lot codes: SK-112, SK-133;
121) 96-2764A, UDI/DI 50649111487871, Lot codes: SK-112;
122) 96-2765, UDI/DI 50649111094185, Lot codes: FST16;
123) 96-2772A, UDI/DI 50649111492585, Lot codes: HSF26;
124) 96-2773A, UDI/DI 50649111492592, Lot codes: SK-133, SK-134;
125) 96-2775, UDI/DI 50649111095793, Lot codes: SK-115;
126) 96-2776A, UDI/DI 50649111492981, Lot codes: SK-115;
127) 96-2777A, UDI/DI 50649111492974, Lot codes: SK-115;
128) 96-2779A, UDI/DI 50649111492967, Lot codes: SK-115;
129) 96-2785A, UDI/DI 50649111488076, Lot codes: HSI;
130) 96-2786A, UDI/DI 50649111488083, Lot codes: HSI;
131) 96-2787A, UDI/DI 50649111488090, Lot codes: HSI;
132) 96-2790A, UDI/DI 50649111488250, Lot codes: SK-112;
133) 96-2791A, UDI/DI 50649111488267, Lot codes: SK-112;
134) 96-2795, UDI/DI 50649111488366, Lot codes: FSF21, FSF24;
135) 96-2921, UDI/DI 50649111120525, Lot codes: FST9;
136) 96-2921A, UDI/DI 50649111480865, Lot codes: HSI;
137) 96-3006, UDI/DI 50649111134720, Lot codes: FSF8, FSF9, FSF26;
138) 96-3010, UDI/DI 50649111135482, Lot codes: FSF21;
139) 96-3015A, UDI/DI 50649111488182, Lot codes: SK-112;
140) 96-3016A, UDI/DI 50649111488199, Lot codes: SK-112;
141) 96-3020A, UDI/DI 50649111493179, Lot codes: HST12;
142) 96-3023A, UDI/DI 50649111493209, Lot codes: HST7;
143) 96-3025A, UDI/DI 50649111493223, Lot codes: HST12;
144) 96-3030A, UDI/DI 50649111492998, Lot codes: SK-134;
145) 96-3558A, UDI/DI 50649111487772, Lot codes: SK-112;
146) 96-3560, UDI/DI 50649111440890, Lot codes: SK-112, SK-131, SK-132;
147) 96-3560A, UDI/DI 50649111487765, Lot codes: SK-112;
148) 96-3566A, UDI/DI 50649111492691, Lot codes: SK-116;
149) 96-3615, UDI/DI 50649111449701, Lot codes: FST10.
|
| FEI Number |
2523865
|
Recalling Firm/
Manufacturer |
Sklar Instruments
1333 Lenape Rd
West Chester PA 19382-6816
|
| For Additional Information Contact | Douglas B. Kraemer
610-430-3200 Ext. 217 |
|---|
Manufacturer Reason
for Recall | Reports of various packaging issues that may result in a breach of the sterile barrier. |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
|---|
| Action | On December 3, 2024 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Action required:
1. Check your inventory for any affected product lots (see Attachment A). If you have affected product in inventory, discontinue use immediately.
2. Notify Additional Users. If you have further distributed any of the items referenced in this notification, you must notify those downstream customers of this recall. Forward a copy of this letter, along with copies of Attachment A and the Recall Acknowledgement form, for such customers to complete and return to Sklar.
3. Notify Sklar. Please complete the enclosed Recall Acknowledgement form as soon as possible, indicating whether you do or do not have any of the affected products remaining in your inventory and whether you have distributed any of the affected products to downstream customers. Return the form to Sklar by e-mail to surgi@sklarcorp.com.
4. Return the affected product. If you do have any of the affected products in inventory, Sklar customer service will contact you to arrange for the affected product to be returned. Sklar will credit its direct customers for returned affected product once it receives the affected product back.
Sklar Instruments is committed to providing high quality, safe, and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have experienced an adverse event associated with any of these products, please contact us and/or report the event to FDA s MedWatch Adverse Event Reporting program online. |
|---|
| Quantity in Commerce | 245015 units |
|---|
| Distribution | Domestic: Nationwide Distribution |
|---|
| 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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| 510(K) Database | 510(K)s with Product Code = GEN
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